ID

43518

Description

Z6051 Registration Worksheet (RW) NCT00726622 Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=42C2D65A-ED39-4B6E-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=42C2D65A-ED39-4B6E-E044-0003BA3F9857

Keywords

  1. 8/27/12 8/27/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/21/15 6/21/15 -
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Z6051 Registration Worksheet (RW) NCT00726622

No Instruction available.

  1. StudyEvent: Z6051 Registration Worksheet (RW)
    1. No Instruction available.
Header Module
Description

Header Module

Visit
Description

AmericanCollegeofSurgeonsOncologyGroupVisitPeriodAmericanCollegeofSurgeonsOncologyGroupVisitPeriodType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25616
UMLS 2011AA Property
C1948053
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C25716
UMLS 2011AA ObjectClass-2
C0545082
Patient ID (Pt. ID issued during registration or previously issued patient ID)
Description

Patient Study ID

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Institution Name
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
NCI Thesaurus ValueDomain-2
C21541
NCI Thesaurus Property
C25364
Institution No.
Description

Institution Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass
C21541
UMLS CUI-2
C0805701
NCI Thesaurus Property
C25364
Has patient previously been registered to an ACOSOG study
Description

PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C16124
UMLS 2011AA ObjectClass-2
C1514463
NCI Thesaurus Property
C19712
UMLS 2011AA Property
C1515944
NCI Metathesaurus Property
CL238692
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Coordinating Group Protocol Number
Description

Protocol ID Coordinating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1711341
NCI Thesaurus Property
C25462
NCI Thesaurus Property-2
C25364
Pre-neoadjuvant Therapy Examination Data
Description

Pre-neoadjuvant Therapy Examination Data

Date of diagnostic endoscopy with biopsy
Description

EndoscopicProcedureBiopsyPerformedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus ObjectClass
C16546
UMLS 2011AA ObjectClass
C0014245
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
Tumor distance from anal verge (cm)
Description

AnalVergeTumorDistanceValue

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
NCI Thesaurus Property
C25167
UMLS 2011AA Property
C0012751
cm
Tumor Size, Largest Dimension (cm)
Description

TumorLargestDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus Property
C25550
UMLS 2011AA Property
C0443228
NCI Thesaurus Property-2
C25483
UMLS 2011AA Property-2
C0439534
cm
Clinical T Stage
Description

ColorectalTumorClinicalTStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25728
UMLS 2011AA Property-2
C0475455
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical N Stage
Description

ColorectalTumorClinicalNStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25580
UMLS 2011AA Property-2
C0456532
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
Clinical M Stage
Description

ColorectalTumorClinicalMStage

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C13363
UMLS 2011AA ObjectClass-2
C0555952
NCI Thesaurus Property
C25398
UMLS 2011AA Property
C0205210
NCI Thesaurus Property-2
C25727
UMLS 2011AA Property-2
C0456533
NCI Thesaurus ValueDomain
C16899
UMLS 2011AA ValueDomain
C1300072
ECOG Performance Status (/Zubrod)
Description

ECOG Performance Status

Data type

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Pregnancy test done
Description

PregnancyTestPerformedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
Date of pregnancy test (If Yes,)
Description

PatientMostRecentPregnancyTestDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Metathesaurus Property
C0032976
NCI Thesaurus Property
C25577
UMLS 2011AA Property
C1513491
Reason pregnancy test not performed
Description

PregnancyLaboratoryProcedureNotPerformedReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

PregnancyLaboratoryProcedureNotPerformedSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25742
UMLS 2011AA ObjectClass
C0032961
NCI Thesaurus ObjectClass-2
C25294
UMLS 2011AA ObjectClass-2
C0022885
NCI Thesaurus Property
C25594
UMLS 2011AA Property
C1518422
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
Description

PreviousCancerIdentifiedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Specify diagnosis
Description

PriorCancerDiagnosisSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Date of Diagnosis of Previous Malignancy
Description

PriorCancerDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C25629
UMLS 2011AA ObjectClass-2
C0332152
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
Neoadjuvant Therapy Date
Description

Neoadjuvant Therapy Date

Start date
Description

NeoadjuvantTreatmentAdministeredBeginDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25431
UMLS 2011AA ValueDomain-2
C0439659
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
End date
Description

NeoadjuvantTreatmentAdministeredEndDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Therapy received
Description

NeoadjuvantTreatmentAdministeredType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Total dose (cGy)
Description

NeoadjuvantTherapyRadiationTherapyAdministeredTotalDose

Data type

float

Alias
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property-2
C25382
UMLS 2011AA Property-2
C1521801
NCI Thesaurus ValueDomain
C25304
UMLS 2011AA ValueDomain
C0439810
NCI Thesaurus ValueDomain-2
C25488
UMLS 2011AA ValueDomain-2
C0178602
Other specify
Description

NeoadjuvantTreatmentAdministeredSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Post-treatment exam done
Description

NeoadjuvantTherapyPostAdministrationEvaluationInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C15665
UMLS 2011AA ObjectClass
C0600558
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C38008
UMLS 2011AA Property-2
C0687676
NCI Thesaurus Property-3
C25409
UMLS 2011AA Property-3
C1533734
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Method of Evaluation (check all that apply)
Description

Evaluation method

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
NCI Thesaurus Property
C16847
Other Specify
Description

Evaluation method, specify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS CUI-1
C2911685
NCI Thesaurus ObjectClass
C20989
UMLS CUI-2
C1521902
NCI Thesaurus Property
C16847
Post-treatment maximum dimension of tumor (cm)
Description

RectalCarcinomaPostNeoadjuvantTherapyDimensionMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C9382
UMLS 2011AA ObjectClass
C0007113
NCI Thesaurus Property
C38008
UMLS 2011AA Property
C0687676
NCI Thesaurus Property-2
C15665
UMLS 2011AA Property-2
C0600558
NCI Thesaurus Property-3
C25483
UMLS 2011AA Property-3
C0439534
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
cm
Footer Module
Description

Footer Module

Completed by
Description

Person Completing Form

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C1550483
NCI Thesaurus ObjectClass
C25657
NCI Thesaurus Property
C25364
Date Form Completed
Description

Date Form Completed

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C1115437
NCI Thesaurus ObjectClass
C40988
NCI Thesaurus Property
C25250
NCI Thesaurus ValueDomain-2
C25367
Patient Information
Description

Patient Information

Registration Date
Description

PatientRegistrationDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Date of Birth
Description

PersonBirthDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25155
UMLS 2011AA Property
C0005615
Gender
Description

Gender

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0079399
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17357
Race
Description

Racial Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25372
UMLS CUI-1
C0034510
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C17049
Ethnicity
Description

EthnicGroupCategoryText

Data type

text

Alias
NCI Thesaurus Property
C25372
UMLS 2011AA Property
C0683312
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ObjectClass
C16564
UMLS 2011AA ObjectClass
C0015031
Method of Payment
Description

PatientPaymentType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Other, specify
Description

PatientPaymentSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25371
UMLS 2011AA Property
C0680264
Weight
Description

Patient Weight

Data type

float

Measurement units
  • Kg
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005910
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25208
Kg
Height
Description

Patient Height

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0489786
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25347
cm
Patient Zip Code
Description

PersonAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Postal code (Canada)
Description

CanadaAddressPostalCode

Data type

text

Alias
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
NCI Thesaurus ObjectClass
C16380
UMLS 2011AA ObjectClass
C0006823
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
Other Country Postal Code (Other)
Description

PatientOtherCountryAddressPostalCode

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25464
UMLS 2011AA Property-2
C0454664
NCI Thesaurus Property-3
C25407
UMLS 2011AA Property-3
C1442065
NCI Thesaurus ValueDomain
C25162
UMLS 2011AA ValueDomain
C0805701
Country of Residence
Description

PersonAddressCountryName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ValueDomain
C25464
UMLS 2011AA ValueDomain
C0454664
NCI Thesaurus Property
C25407
UMLS 2011AA Property
C1442065
NCI Thesaurus ValueDomain-2
C42614
UMLS 2011AA ValueDomain-2
C0027365
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
HIPAA Authorization form (OR)
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date
Description

PatientSignedDischargeMedicalRecordDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Eligibility Criteria
Description

Eligibility Criteria

Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)
Description

RectalCarcinomaAdenocarcinomaHistologyDiagnosisInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C9382
UMLS 2011AA ObjectClass
C0007113
NCI Thesaurus Property
C16681
UMLS 2011AA Property
C0019638
NCI Thesaurus Property-2
C2852
UMLS 2011AA Property-2
C0001418
NCI Thesaurus Property-3
C15220
UMLS 2011AA Property-3
C0011900
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
T3N0M0, T1-3N1-2M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible
Description

RectalCarcinomaStageInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C16899
UMLS 2011AA Property
C1300072
NCI Thesaurus ObjectClass
C9382
UMLS 2011AA ObjectClass
C0007113
Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
Description

PreoperativeTherapeuticProcedureCompleteInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C54732
UMLS 2011AA ObjectClass
C0445204
NCI Thesaurus ObjectClass-2
C49236
UMLS 2011AA ObjectClass-2
C0087111
Age >= 18 years
Description

PatientAgeInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
ECOG (Zubrod) Performance Status <= 2
Description

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C25491
UMLS 2011AA ObjectClass
C1512162
NCI Metathesaurus ObjectClass
CL092952
Body Mass Index <= 34 (The same value applies to both male and female patients)
Description

BodyMassIndexEvaluationInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus ObjectClass
C16358
UMLS 2011AA ObjectClass
C1305855
No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
Description

DiseaseorDisorderLaparoscopyPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C16969
UMLS 2011AA Property-2
C0031150
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation)
Description

SevereDisabledDiseasesandDisordersPresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C63367
UMLS 2011AA ObjectClass
C1880351
NCI Thesaurus ObjectClass-2
C2991
UMLS 2011AA ObjectClass-2
C0012634
NCI Thesaurus ObjectClass-3
C70667
UMLS 2011AA ObjectClass-3
C0205082
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Description

PsychiatricDiseaseHistoryInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C2893
UMLS 2011AA Property
C0004936
NCI Thesaurus Property-2
C18772
UMLS 2011AA Property-2
C0262926
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
Description

PreviousCancerIdentifiedInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C25737
UMLS 2011AA Property
C0205396
Randomization
Description

Randomization

Randomization
Description

AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus ObjectClass
C19712
UMLS 2011AA ObjectClass
C1515944
NCI Thesaurus ObjectClass-2
C15538
UMLS 2011AA ObjectClass-2
C1522541
Colorectal Surgical Procedure
Description

Colorectal Surgical Procedure

Planned operative procedure
Description

ColorectalSurgicalProcedurePlannedColorectalSurgicalProcedurePerformedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C13363
UMLS 2011AA ObjectClass
C0555952
NCI Thesaurus ObjectClass-2
C15329
UMLS 2011AA ObjectClass-2
C0543467
NCI Thesaurus Property
C25619
UMLS 2011AA Property
C1301732
Site of primary tumor
Description

RectalCarcinomaLocationAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C9382
UMLS 2011AA ObjectClass
C0007113
Date of CT/MRI scan
Description

DiagnosticImagingComputedTomographyMagneticResonanceImagingPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C17204
UMLS 2011AA Property
C0040405
NCI Thesaurus Property-2
C38000
UMLS 2011AA Property-2
C0884358
NCI Thesaurus Property-3
C16809
UMLS 2011AA Property-3
C0024485
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Date of EUS/MRI scan
Description

DiagnosticImagingMagneticResonanceImagingEndoscopicUltrasoundPerformedDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C16502
UMLS 2011AA ObjectClass
C0011923
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus Property-2
C16809
UMLS 2011AA Property-2
C0024485
NCI Thesaurus Property-3
C46078
UMLS 2011AA Property-3
C0376443
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Consent
Description

Consent

My tissue specimens (if available) may be kept for use in future research to learn about, prevent, or treat cancer.
Description

TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25648
UMLS 2011AA Property
C0439849
NCI Thesaurus Property-3
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
My tissue specimens (if available) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer¿s disease, or heart disease).
Description

TissueSpecimenResearchConsentUnrelatedInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
UMLS 2011AA ObjectClass
C0040300
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ValueDomain-2
C25328
UMLS 2011AA ValueDomain-2
C0445356
My tissue specimens (if available) may be kept for use in future genetic research.
Description

PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property-2
C0006826
NCI Thesaurus Property-3
C17938
UMLS 2011AA Property-3
C0314603
NCI Thesaurus Property-4
C19157
UMLS 2011AA Property-4
C0370003
NCI Thesaurus Property-5
C25460
UMLS 2011AA Property-5
C1511481
NCI Thesaurus Property-6
C16203
UMLS 2011AA Property-6
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698

Similar models

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  1. StudyEvent: Z6051 Registration Worksheet (RW)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
Item
Visit
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus ObjectClass-2)
C0545082 (UMLS 2011AA ObjectClass-2)
Code List
Visit
CL Item
Prior To Registration (Prior to Registration)
Patient Study ID
Item
Patient ID (Pt. ID issued during registration or previously issued patient ID)
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Name
Item
Institution Name
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Institution Number
Item
Institution No.
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
PriorTherapyPatientAmericanCollegeofSurgeonsOncologyGroupStudyInd-2
Item
Has patient previously been registered to an ACOSOG study
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C16124 (NCI Thesaurus ObjectClass-2)
C1514463 (UMLS 2011AA ObjectClass-2)
C19712 (NCI Thesaurus Property)
C1515944 (UMLS 2011AA Property)
CL238692 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Protocol ID Coordinating Group
Item
Coordinating Group Protocol Number
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1711341 (UMLS CUI-2)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)
Item Group
Pre-neoadjuvant Therapy Examination Data
EndoscopicProcedureBiopsyPerformedDate
Item
Date of diagnostic endoscopy with biopsy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C16546 (NCI Thesaurus ObjectClass)
C0014245 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
AnalVergeTumorDistanceValue
Item
Tumor distance from anal verge (cm)
float
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)
TumorLargestDimensionMeasurement
Item
Tumor Size, Largest Dimension (cm)
float
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property-2)
C0439534 (UMLS 2011AA Property-2)
Item
Clinical T Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property-2)
C0475455 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Clinical T Stage
CL Item
Tumor Invades Submucosa (T1)
CL Item
Tumor Invades Muscularis Propria (T2)
CL Item
Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)
CL Item
Tumor Directly Invades Other Organs Or Structures, And/or Perforates Visceral Peritoneum (T4)
Item
Clinical N Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property-2)
C0456532 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Clinical N Stage
CL Item
No Regional Lymph Node Metastasis (N0)
CL Item
Metastasis In 1 To 3 Regional Lymph Nodes (N1)
CL Item
Metastasis In 4 Or More Regional Lymph Nodes (N2)
Item
Clinical M Stage
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C13363 (NCI Thesaurus ObjectClass-2)
C0555952 (UMLS 2011AA ObjectClass-2)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property-2)
C0456533 (UMLS 2011AA Property-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
Code List
Clinical M Stage
CL Item
No Distant Metastases (M0)
CL Item
Distant Metastasis (M1)
C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)
Item
ECOG Performance Status (/Zubrod)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status (/Zubrod)
CL Item
Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)
CL Item
Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)
CL Item
Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)
CL Item
Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)
CL Item
Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)
PregnancyTestPerformedInd-2
Item
Pregnancy test done
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
PatientMostRecentPregnancyTestDate
Item
Date of pregnancy test (If Yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C0032976 (NCI Metathesaurus Property)
C25577 (NCI Thesaurus Property)
C1513491 (UMLS 2011AA Property)
Item
Reason pregnancy test not performed
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Reason pregnancy test not performed
CL Item
Patient Is Male (Patient is male)
CL Item
Patient Is Female But Is Not Of Childbearing Potential (Patient is female but is not of childbearing potential)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
PregnancyLaboratoryProcedureNotPerformedSpecify
Item
Other, specify
text
C25742 (NCI Thesaurus ObjectClass)
C0032961 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus ObjectClass-2)
C0022885 (UMLS 2011AA ObjectClass-2)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PreviousCancerIdentifiedInd-2
Item
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
PriorCancerDiagnosisSpecify
Item
Specify diagnosis
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
PriorCancerDiagnosisDate
Item
Date of Diagnosis of Previous Malignancy
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item Group
Neoadjuvant Therapy Date
NeoadjuvantTreatmentAdministeredBeginDate
Item
Start date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
NeoadjuvantTreatmentAdministeredEndDate
Item
End date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Item
Therapy received
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
Code List
Therapy received
CL Item
Infusional Fluorouracil (Infusional 5FU)
CL Item
Bolus Fluorouracil (Bolus 5FU)
CL Item
Capecitabine (Capecitabine)
C1794 (NCI Thesaurus)
C0671970 (UMLS 2011AA)
CL Item
Radiation Therapy (Radiation Therapy)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
NeoadjuvantTherapyRadiationTherapyAdministeredTotalDose
Item
Total dose (cGy)
float
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)
C0178602 (UMLS 2011AA ValueDomain-2)
NeoadjuvantTreatmentAdministeredSpecify
Item
Other specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
NeoadjuvantTherapyPostAdministrationEvaluationInd-2
Item
Post-treatment exam done
boolean
C15665 (NCI Thesaurus ObjectClass)
C0600558 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property-2)
C0687676 (UMLS 2011AA Property-2)
C25409 (NCI Thesaurus Property-3)
C1533734 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Method of Evaluation (check all that apply)
text
C25284 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C16847 (NCI Thesaurus Property)
Code List
Method of Evaluation (check all that apply)
CL Item
Ct Scan (CT scan)
CL Item
Mri Scan (MRI scan)
CL Item
Ultrasound (Ultrasound)
C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
Evaluation method, specify
Item
Other Specify
text
C25685 (NCI Thesaurus ValueDomain)
C2911685 (UMLS CUI-1)
C20989 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C16847 (NCI Thesaurus Property)
RectalCarcinomaPostNeoadjuvantTherapyDimensionMeasurement
Item
Post-treatment maximum dimension of tumor (cm)
float
C9382 (NCI Thesaurus ObjectClass)
C0007113 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property-2)
C0600558 (UMLS 2011AA Property-2)
C25483 (NCI Thesaurus Property-3)
C0439534 (UMLS 2011AA Property-3)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
Item Group
Footer Module
Person Completing Form
Item
Completed by
text
C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
Date Form Completed
Item
Date Form Completed
date
C25164 (NCI Thesaurus ValueDomain)
C1115437 (UMLS CUI-1)
C40988 (NCI Thesaurus ObjectClass)
C25250 (NCI Thesaurus Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item Group
Patient Information
PatientRegistrationDate
Item
Registration Date
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25367 (NCI Thesaurus ValueDomain-2)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
PersonBirthDate
Item
Date of Birth
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25155 (NCI Thesaurus Property)
C0005615 (UMLS 2011AA Property)
Item
Gender
text
C25372 (NCI Thesaurus ValueDomain)
C0079399 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17357 (NCI Thesaurus Property)
Code List
Gender
CL Item
Male Gender (MALE)
C46109 (NCI Thesaurus)
C1706180 (UMLS 2011AA)
CL Item
Female Gender (FEMALE)
C46110 (NCI Thesaurus)
C0086287 (UMLS 2011AA)
Item
Race
text
C25372 (NCI Thesaurus ValueDomain)
C0034510 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C17049 (NCI Thesaurus Property)
Code List
Race
CL Item
A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)
C41259 (NCI Thesaurus)
C1515945 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)
C41260 (NCI Thesaurus)
C0078988 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)
C16352 (NCI Thesaurus)
C0085756 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Hawaii, Guam, Samoa, Or Other Pacific Islands. (Native Hawaiian or other Pacific Islander)
C41219 (NCI Thesaurus)
C1513907 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)
C41261 (NCI Thesaurus)
C0007457 (UMLS 2011AA)
Item
Ethnicity
text
C25372 (NCI Thesaurus Property)
C0683312 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16564 (NCI Thesaurus ObjectClass)
C0015031 (UMLS 2011AA ObjectClass)
Code List
Ethnicity
CL Item
A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)
C17459 (NCI Thesaurus)
C0086409 (UMLS 2011AA)
CL Item
A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)
C41222 (NCI Thesaurus)
C1518424 (UMLS 2011AA)
CL Item
Could Not Be Determined Or Unsure (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Method of Payment
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Code List
Method of Payment
CL Item
Medicaid (Medicaid)
C0025071 (NCI Metathesaurus)
CL Item
Medicaid And Medicare (Medicaid and Medicare)
CL Item
Medicare (Medicare)
C16665 (NCI Thesaurus)
C0018717 (UMLS 2011AA)
CL Item
Medicare And Private Insurance (Medicare and Private Insurance)
CL Item
Military Or Veterans Sponsored Nos (Military or Veterans Sponsored, Not Otherwise Specified (NOS))
CL Item
Military Sponsored (including Champus & Tricare) (Military Sponsored (including CHAMPUS & TRICARE))
CL Item
No Means Of Payment (no Insurance) (No means of payment (no insurance))
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Private Insurance (Private Insurance)
CL Item
Self Pay (no Insurance) (Self Pay (No Insurance))
CL Item
Veterans Sponsored (Veterans Sponsored)
PatientPaymentSpecify
Item
Other, specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25371 (NCI Thesaurus Property)
C0680264 (UMLS 2011AA Property)
Patient Weight
Item
Weight
float
C25209 (NCI Thesaurus ValueDomain)
C0005910 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25208 (NCI Thesaurus Property)
Patient Height
Item
Height
float
C25209 (NCI Thesaurus ValueDomain)
C0489786 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25347 (NCI Thesaurus Property)
PersonAddressPostalCode
Item
Patient Zip Code
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
CanadaAddressPostalCode
Item
Postal code (Canada)
text
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
C16380 (NCI Thesaurus ObjectClass)
C0006823 (UMLS 2011AA ObjectClass)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
PatientOtherCountryAddressPostalCode
Item
Other Country Postal Code (Other)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25464 (NCI Thesaurus Property-2)
C0454664 (UMLS 2011AA Property-2)
C25407 (NCI Thesaurus Property-3)
C1442065 (UMLS 2011AA Property-3)
C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)
PersonAddressCountryName
Item
Country of Residence
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25464 (NCI Thesaurus ValueDomain)
C0454664 (UMLS 2011AA ValueDomain)
C25407 (NCI Thesaurus Property)
C1442065 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain-2)
C0027365 (UMLS 2011AA ValueDomain-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
HIPAA Authorization form (OR)
text
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
Code List
HIPAA Authorization form (OR)
CL Item
Included In Study Informed Consent (Included in Study Informed Consent)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Eligibility Criteria
RectalCarcinomaAdenocarcinomaHistologyDiagnosisInd-2
Item
Histologic diagnosis of adenocarcinoma of the rectum (<= 12cm from the anal verge)
boolean
C9382 (NCI Thesaurus ObjectClass)
C0007113 (UMLS 2011AA ObjectClass)
C16681 (NCI Thesaurus Property)
C0019638 (UMLS 2011AA Property)
C2852 (NCI Thesaurus Property-2)
C0001418 (UMLS 2011AA Property-2)
C15220 (NCI Thesaurus Property-3)
C0011900 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
RectalCarcinomaStageInd-2
Item
T3N0M0, T1-3N1-2M0 disease as determined by pre-neoadjuvant therapy CT scans and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16899 (NCI Thesaurus Property)
C1300072 (UMLS 2011AA Property)
C9382 (NCI Thesaurus ObjectClass)
C0007113 (UMLS 2011AA ObjectClass)
PreoperativeTherapeuticProcedureCompleteInd-2
Item
Completion of pre-operative 5FU-based chemotherapy and/or radiation therapy. Capecitabine may be substituted for 5FU.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C54732 (NCI Thesaurus ObjectClass)
C0445204 (UMLS 2011AA ObjectClass)
C49236 (NCI Thesaurus ObjectClass-2)
C0087111 (UMLS 2011AA ObjectClass-2)
PatientAgeInd-2
Item
Age >= 18 years
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
ECOG (Zubrod) Performance Status <= 2
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25491 (NCI Thesaurus ObjectClass)
C1512162 (UMLS 2011AA ObjectClass)
CL092952 (NCI Metathesaurus ObjectClass)
BodyMassIndexEvaluationInd-2
Item
Body Mass Index <= 34 (The same value applies to both male and female patients)
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C16358 (NCI Thesaurus ObjectClass)
C1305855 (UMLS 2011AA ObjectClass)
DiseaseorDisorderLaparoscopyPresentInd-2
Item
No evidence of conditions that would preclude use of a laparoscopic approach (e.g., multiple previous major laparotomies, severe adhesions).
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C16969 (NCI Thesaurus Property-2)
C0031150 (UMLS 2011AA Property-2)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
SevereDisabledDiseasesandDisordersPresentInd-2
Item
No systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery. No other severe incapacitating disease, i.e., ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation)
boolean
C63367 (NCI Thesaurus ObjectClass)
C1880351 (UMLS 2011AA ObjectClass)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)
C70667 (NCI Thesaurus ObjectClass-3)
C0205082 (UMLS 2011AA ObjectClass-3)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PsychiatricDiseaseHistoryInd-2
Item
No history of psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C2893 (NCI Thesaurus Property)
C0004936 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property-2)
C0262926 (UMLS 2011AA Property-2)
PreviousCancerIdentifiedInd-2
Item
No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal) within five years prior to registration.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25737 (NCI Thesaurus Property)
C0205396 (UMLS 2011AA Property)
Item Group
Randomization
Item
Randomization
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C19712 (NCI Thesaurus ObjectClass)
C1515944 (UMLS 2011AA ObjectClass)
C15538 (NCI Thesaurus ObjectClass-2)
C1522541 (UMLS 2011AA ObjectClass-2)
Code List
Randomization
CL Item
Open Laparotomy And Rectal Resection (Open laparotomy and rectal resection)
CL Item
Laparoscopic-assisted Rectal Resection (Laparoscopic-assisted rectal resection)
Item Group
Colorectal Surgical Procedure
Item
Planned operative procedure
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13363 (NCI Thesaurus ObjectClass)
C0555952 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25619 (NCI Thesaurus Property)
C1301732 (UMLS 2011AA Property)
Code List
Planned operative procedure
CL Item
Z6051-f2-l1 (Low anterior resection)
CL Item
Z6051-f2-l2 (Abdominal perineal resection)
Item
Site of primary tumor
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9382 (NCI Thesaurus ObjectClass)
C0007113 (UMLS 2011AA ObjectClass)
Code List
Site of primary tumor
CL Item
Z6051-f1-l1 (High rectum)
CL Item
Z6051-f1-l2 (Middle rectum)
CL Item
Z6051-f1-l3 (Low rectum)
DiagnosticImagingComputedTomographyMagneticResonanceImagingPerformedDate
Item
Date of CT/MRI scan
date
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C17204 (NCI Thesaurus Property)
C0040405 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C16809 (NCI Thesaurus Property-3)
C0024485 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
DiagnosticImagingMagneticResonanceImagingEndoscopicUltrasoundPerformedDate
Item
Date of EUS/MRI scan
date
C16502 (NCI Thesaurus ObjectClass)
C0011923 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C16809 (NCI Thesaurus Property-2)
C0024485 (UMLS 2011AA Property-2)
C46078 (NCI Thesaurus Property-3)
C0376443 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Consent
TissueSpecimenMalignantNeoplasmRelatedResearchConsentInd-3
Item
My tissue specimens (if available) may be kept for use in future research to learn about, prevent, or treat cancer.
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25648 (NCI Thesaurus Property-2)
C0439849 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-3)
C0006826 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
TissueSpecimenResearchConsentUnrelatedInd-3
Item
My tissue specimens (if available) may be kept for use in research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer¿s disease, or heart disease).
boolean
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C15319 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25328 (NCI Thesaurus ValueDomain-2)
C0445356 (UMLS 2011AA ValueDomain-2)
PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2
Item
My tissue specimens (if available) may be kept for use in future genetic research.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property-2)
C17938 (NCI Thesaurus Property-3)
C0314603 (UMLS 2011AA Property-3)
C19157 (NCI Thesaurus Property-4)
C0370003 (UMLS 2011AA Property-4)
C25460 (NCI Thesaurus Property-5)
C1511481 (UMLS 2011AA Property-5)
C16203 (NCI Thesaurus Property-6)
C1516654 (UMLS 2011AA Property-6)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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