ID

9032

Descripción

ACOSOG-Z4099 OPEN Enrollment Form Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=977826FD-FE23-332B-E040-BB89AD437C06

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=977826FD-FE23-332B-E040-BB89AD437C06

Palabras clave

Versiones (2)
  1. 19/9/12 19/9/12 -
  2. 9/1/15 9/1/15 - Martin Dugas
Subido en

9 de enero de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Lung Cancer NCT01336894 Registration - ACOSOG-Z4099 OPEN Enrollment Form - 3167507v1.0

Inglés

No Instruction available.

1 formularios  
  1. StudyEvent: ACOSOG-Z4099 OPEN Enrollment Form
    1. No Instruction available.
General Information
Descripción

General Information

Pt ID# (Local Patient Identifier)
Descripción

PatientIdentifier

Tipo de datos

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25364
UMLS 2011AA ValueDomain
C0600091
Last (initial)
Descripción

Patient Initials Last

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1517741
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25551
First (initial)
Descripción

Patient Initials First

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C0205435
NCI Thesaurus Property
C25536
NCI Thesaurus Property-2
C25509
Middle (initial optional)
Descripción

PatientMiddleInitialsName

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25536
UMLS 2011AA Property
C1555582
NCI Thesaurus Property-2
C25569
UMLS 2011AA Property-2
C0444598
Date Informed Consent Signed (month day year)
Descripción

InformedConsentFormSignedDate

Tipo de datos

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
Was HIPAA Authorization included in Study Informed Consent
Descripción

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date (If no month day year)
Descripción

PatientSignedDischargeMedicalRecordDate

Tipo de datos

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
Stratification Factors
Descripción

Stratification Factors

Institutional intent to use Brachytherapy
Descripción

InstitutionTherapeuticProcedureIntentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C49236
UMLS 2011AA Property
C0087111
NCI Thesaurus ObjectClass
C41206
UMLS 2011AA ObjectClass
C1272753
NCI Thesaurus Property-2
C25725
UMLS 2011AA Property-2
C1283828
ECOG Performance Status (PS)
Descripción

ECOG Performance Status

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Eligibility Checklist
Descripción

Eligibility Checklist

Age >= 18 years
Descripción

PatientAgeInd-2

Tipo de datos

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
Age (>= 18)
Descripción

PatientAgeValue

Tipo de datos

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25150
UMLS 2011AA Property
C0001779
ECOG performance status (PS) 0, 1, or 2
Descripción

EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2

Tipo de datos

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
Biopsy-proven non-small cell lung cancer (NSCLC).
Descripción

PatientBiopsyNon-SmallCellLungCarcinomaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15189
UMLS 2011AA Property
C0005558
NCI Thesaurus Property-2
C2926
UMLS 2011AA Property-2
C0007131
Tumor <=3 cm maximum diameter, clinical stage Ia or selected Ib (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration.
Descripción

PersonRadiologyDiseaseorDisorderEvaluationPriorRegistrationDiagnosticImagingClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C17059
UMLS 2011AA Property-2
C0034599
NCI Thesaurus Property-3
C16502
UMLS 2011AA Property-3
C0011923
NCI Thesaurus Property-4
C25646
UMLS 2011AA Property-4
C1514821
NCI Thesaurus Property-5
C25629
UMLS 2011AA Property-5
C0332152
NCI Thesaurus Property-6
C2991
UMLS 2011AA Property-6
C0012634
NCI Thesaurus Property-7
C16112
UMLS 2011AA Property-7
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of PET/CT scan (chest and upper abdomen)
Descripción

PositronEmissionTomographyComputedTomographyScanPerformedDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Metathesaurus ObjectClass
C1139717
All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy.
Descripción

MediastinalLymphNodePhysicalExaminationInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ObjectClass
C12745
UMLS 2011AA ObjectClass
C0024204
NCI Thesaurus ObjectClass-2
C25310
UMLS 2011AA ObjectClass-2
C1522718
Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
Descripción

PersonThoracicSurgeonEvaluationClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25214
UMLS 2011AA Property
C0220825
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C17836
UMLS 2011AA Property-3
C0278626
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Tumor located peripherally within the lung. (NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See the diagram in Section 2.2. Patients with non-peripheral central tumors are NOT eligible.)
Descripción

PersonLungNeoplasmPeripheralInvolvementClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Thesaurus Property-3
C25233
UMLS 2011AA Property-3
C0205100
NCI Thesaurus Property-4
C3200
UMLS 2011AA Property-4
C0020445
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No evidence of distant metastases.
Descripción

PersonNoDistantMetastasisClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
NCI Metathesaurus Property
CL031818
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
PFTs with DLCO within 90 days prior to registration.
Descripción

PersonPulmonaryFunctionTestCarbonMonoxideDiffusingCapabilityTestPriorRegistrationClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25646
UMLS 2011AA Property
C1514821
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C38083
UMLS 2011AA Property-4
C1516251
NCI Thesaurus Property-5
C38081
UMLS 2011AA Property-5
C0024119
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below: Major Criteria: FEV1 <= 50% predicted DLCO <= 50% predicted Minor Criteria: Age >= 75 FEV1 51-60% predicted DLCO 51-60% predicted Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mmHg) as estimated by echocardiography or right heart catheterization) Poor left ventricular function (defined as an ejection fraction of 40% or less) Resting or Exercise Arterial pO2 <= 55 mm Hg or SpO2 <= 88% pCO2 >45 mm Hg Modified Medical Research Council (MMRC) Dyspnea Scale >= 3 (see table within Section 2.1)
Descripción

PersonElevatedRiskSurgicalProcedureClinicalTrialEligibilityCriteriaEligibilityInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15329
UMLS 2011AA Property
C0543467
NCI Thesaurus Property-2
C25493
UMLS 2011AA Property-2
C0205250
NCI Thesaurus Property-3
C17102
UMLS 2011AA Property-3
C0035647
NCI Thesaurus Property-4
C16112
UMLS 2011AA Property-4
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
No prior intra-thoracic radiation therapy. (Note: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted. Previous chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted.)
Descripción

PersonNoPriorThoracicRadiationTherapyClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C15313
UMLS 2011AA Property-2
C1522449
NCI Thesaurus Property-3
C25629
UMLS 2011AA Property-3
C0332152
NCI Thesaurus Property-4
C13360
UMLS 2011AA Property-4
C0817096
NCI Thesaurus Property-5
C16112
UMLS 2011AA Property-5
C1516637
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Non-pregnant and non-lactating. Women of childbearing potential must have a negative urine or serum pregnancy test within 60 days prior to registration. Peri-menopausal women must be amenorrheic >= 12 months prior to registration to be considered not of childbearing potential. (If not a female of child-bearing potential check NA)
Descripción

PatientNegativePregnancyTestIndicator

Tipo de datos

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
Negative urine or serum pregnancy test date (If female of child-bearing potential)
Descripción

PatientNegativePregnancyTestDate

Tipo de datos

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25247
UMLS 2011AA Property
C0205160
NCI Metathesaurus Property
C0032976
No prior invasive malignancy, unless disease-free for >= 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
Descripción

PersonNoPriorInvasiveMalignantNeoplasmClinicalTrialEligibilityCriteriaInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C49487
UMLS 2011AA Property
C1298908
NCI Thesaurus Property-2
C25629
UMLS 2011AA Property-2
C0332152
NCI Thesaurus Property-3
C16112
UMLS 2011AA Property-3
C1516637
NCI Thesaurus Property-4
C8505
UMLS 2011AA Property-4
C0677898
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specimen Collection And Banking Consent
Descripción

Specimen Collection And Banking Consent

Patient has given permission for blood specimen collection for use in this study.
Descripción

PatientBloodSpecimenConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C12434
UMLS 2011AA Property
C0229664
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep blood sample(s) for use in future research to learn about, prevent, or treat cancer.
Descripción

BloodSpecimenFutureUsePatientConsentIndicator

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus Property-3
C25340
UMLS 2011AA Property-3
C0457083
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep blood sample(s) for use in future research to learn about genetics and how they relate to cancer. This may also include research on inherited traits (genes passed on in families).
Descripción

BloodSpecimenRelatedGeneticResearchConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
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
C17938
UMLS 2011AA Property-2
C0314603
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep blood sample(s) for use in future research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include genetic research on inherited traits (genes passed on in families).
Descripción

BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C12434
UMLS 2011AA ObjectClass
C0229664
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
UMLS 2011AA Property-2
C0012634
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer.
Descripción

PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2

Tipo de datos

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
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16203
UMLS 2011AA Property-5
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Patient has given permission to keep tissue sample(s) for use in future research to learn about genetics and how they relate to cancer. This may also include research on inherited traits (genes passed on in families).
Descripción

PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2

Tipo de datos

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
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include genetic research on inherited traits (genes passed on in families).
Descripción

PersonSpecimenFutureUnrelatedClinicalorResearchActivityConsentInd-2

Tipo de datos

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C25328
UMLS 2011AA Property-2
C0445356
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-3
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-4
C1511481
NCI Thesaurus Property-5
C16203
UMLS 2011AA Property-5
C1516654
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Randomization
Descripción

Randomization

Randomization
Descripción

AmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationAmericanCollegeofSurgeonsOncologyGroupTreatmentArmRandomizationType

Tipo de datos

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
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No Instruction available.

1 formularios
  1. StudyEvent: ACOSOG-Z4099 OPEN Enrollment Form
    1. No Instruction available.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General Information
PatientIdentifier
Item
Pt ID# (Local Patient Identifier)
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25364 (NCI Thesaurus ValueDomain)
C0600091 (UMLS 2011AA ValueDomain)
Patient Initials Last
Item
Last (initial)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1517741 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25551 (NCI Thesaurus Property-2)
Patient Initials First
Item
First (initial)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C0205435 (UMLS CUI-2)
C25536 (NCI Thesaurus Property)
C25509 (NCI Thesaurus Property-2)
PatientMiddleInitialsName
Item
Middle (initial optional)
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)
C25569 (NCI Thesaurus Property-2)
C0444598 (UMLS 2011AA Property-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed (month day year)
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)
HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator
Item
Was HIPAA Authorization included in Study Informed Consent
boolean
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date (If no month day year)
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
Stratification Factors
InstitutionTherapeuticProcedureIntentInd-2
Item
Institutional intent to use Brachytherapy
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C49236 (NCI Thesaurus Property)
C0087111 (UMLS 2011AA Property)
C41206 (NCI Thesaurus ObjectClass)
C1272753 (UMLS 2011AA ObjectClass)
C25725 (NCI Thesaurus Property-2)
C1283828 (UMLS 2011AA Property-2)
Item
ECOG Performance Status (PS)
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
CL.3
Code List
ECOG Performance Status (PS)
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)
Item Group
Eligibility Checklist
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)
PatientAgeValue
Item
Age (>= 18)
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS 2011AA Property)
EasternCooperativeOncologyGroupPerformanceStatusAssessmentInd-2
Item
ECOG performance status (PS) 0, 1, or 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)
PatientBiopsyNon-SmallCellLungCarcinomaInd-2
Item
Biopsy-proven non-small cell lung cancer (NSCLC).
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C2926 (NCI Thesaurus Property-2)
C0007131 (UMLS 2011AA Property-2)
PersonRadiologyDiseaseorDisorderEvaluationPriorRegistrationDiagnosticImagingClinicalTrialEligibilityCriteriaInd-2
Item
Tumor <=3 cm maximum diameter, clinical stage Ia or selected Ib (i.e., with visceral pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60 days prior to registration.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C17059 (NCI Thesaurus Property-2)
C0034599 (UMLS 2011AA Property-2)
C16502 (NCI Thesaurus Property-3)
C0011923 (UMLS 2011AA Property-3)
C25646 (NCI Thesaurus Property-4)
C1514821 (UMLS 2011AA Property-4)
C25629 (NCI Thesaurus Property-5)
C0332152 (UMLS 2011AA Property-5)
C2991 (NCI Thesaurus Property-6)
C0012634 (UMLS 2011AA Property-6)
C16112 (NCI Thesaurus Property-7)
C1516637 (UMLS 2011AA Property-7)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PositronEmissionTomographyComputedTomographyScanPerformedDate
Item
Date of PET/CT scan (chest and upper abdomen)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C1139717 (NCI Metathesaurus ObjectClass)
MediastinalLymphNodePhysicalExaminationInd-2
Item
All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis dimension on CT scan and/or positive on PET scan) confirmed negative for involvement with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy, EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy.
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass-2)
C1522718 (UMLS 2011AA ObjectClass-2)
PersonThoracicSurgeonEvaluationClinicalTrialEligibilityCriteriaInd-2
Item
Tumor verified by a thoracic surgeon to be in a location that will permit sublobar resection.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C17836 (NCI Thesaurus Property-3)
C0278626 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonLungNeoplasmPeripheralInvolvementClinicalTrialEligibilityCriteriaInd-2
Item
Tumor located peripherally within the lung. (NOTE: Peripheral is defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions. See the diagram in Section 2.2. Patients with non-peripheral central tumors are NOT eligible.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
C25233 (NCI Thesaurus Property-3)
C0205100 (UMLS 2011AA Property-3)
C3200 (NCI Thesaurus Property-4)
C0020445 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNoDistantMetastasisClinicalTrialEligibilityCriteriaInd-2
Item
No evidence of distant metastases.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
CL031818 (NCI Metathesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonPulmonaryFunctionTestCarbonMonoxideDiffusingCapabilityTestPriorRegistrationClinicalTrialEligibilityCriteriaInd-2
Item
PFTs with DLCO within 90 days prior to registration.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus Property)
C1514821 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C38083 (NCI Thesaurus Property-4)
C1516251 (UMLS 2011AA Property-4)
C38081 (NCI Thesaurus Property-5)
C0024119 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonElevatedRiskSurgicalProcedureClinicalTrialEligibilityCriteriaEligibilityInd-2
Item
Patient at high-risk for surgery by meeting a minimum of one major criteria or two minor criteria as described below: Major Criteria: FEV1 <= 50% predicted DLCO <= 50% predicted Minor Criteria: Age >= 75 FEV1 51-60% predicted DLCO 51-60% predicted Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mmHg) as estimated by echocardiography or right heart catheterization) Poor left ventricular function (defined as an ejection fraction of 40% or less) Resting or Exercise Arterial pO2 <= 55 mm Hg or SpO2 <= 88% pCO2 >45 mm Hg Modified Medical Research Council (MMRC) Dyspnea Scale >= 3 (see table within Section 2.1)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus Property)
C0543467 (UMLS 2011AA Property)
C25493 (NCI Thesaurus Property-2)
C0205250 (UMLS 2011AA Property-2)
C17102 (NCI Thesaurus Property-3)
C0035647 (UMLS 2011AA Property-3)
C16112 (NCI Thesaurus Property-4)
C1516637 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonNoPriorThoracicRadiationTherapyClinicalTrialEligibilityCriteriaInd-2
Item
No prior intra-thoracic radiation therapy. (Note: Previous radiotherapy as part of treatment for head and neck, breast, or other non-thoracic cancer is permitted. Previous chemotherapy or surgical resection for the lung cancer being treated on this protocol is NOT permitted.)
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C15313 (NCI Thesaurus Property-2)
C1522449 (UMLS 2011AA Property-2)
C25629 (NCI Thesaurus Property-3)
C0332152 (UMLS 2011AA Property-3)
C13360 (NCI Thesaurus Property-4)
C0817096 (UMLS 2011AA Property-4)
C16112 (NCI Thesaurus Property-5)
C1516637 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Non-pregnant and non-lactating. Women of childbearing potential must have a negative urine or serum pregnancy test within 60 days prior to registration. Peri-menopausal women must be amenorrheic >= 12 months prior to registration to be considered not of childbearing potential. (If not a female of child-bearing potential check NA)
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
CL.15
Code List
Non-pregnant and non-lactating. Women of childbearing potential must have a negative urine or serum pregnancy test within 60 days prior to registration. Peri-menopausal women must be amenorrheic >= 12 months prior to registration to be considered not of childbearing potential. (If not a female of child-bearing potential check NA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
N/a (N/A)
PatientNegativePregnancyTestDate
Item
Negative urine or serum pregnancy test date (If female of child-bearing potential)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25247 (NCI Thesaurus Property)
C0205160 (UMLS 2011AA Property)
C0032976 (NCI Metathesaurus Property)
PersonNoPriorInvasiveMalignantNeoplasmClinicalTrialEligibilityCriteriaInd-2
Item
No prior invasive malignancy, unless disease-free for >= 3 years prior to registration (exceptions: non-melanoma skin cancer, in-situ cancers).
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C49487 (NCI Thesaurus Property)
C1298908 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property-2)
C0332152 (UMLS 2011AA Property-2)
C16112 (NCI Thesaurus Property-3)
C1516637 (UMLS 2011AA Property-3)
C8505 (NCI Thesaurus Property-4)
C0677898 (UMLS 2011AA Property-4)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Specimen Collection And Banking Consent
PatientBloodSpecimenConsentInd-2
Item
Patient has given permission for blood specimen collection for use in this study.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C12434 (NCI Thesaurus Property)
C0229664 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodSpecimenFutureUsePatientConsentIndicator
Item
Patient has given permission to keep blood sample(s) for use in future research to learn about, prevent, or treat cancer.
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-2)
C1511481 (UMLS 2011AA Property-2)
C25340 (NCI Thesaurus Property-3)
C0457083 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodSpecimenRelatedGeneticResearchConsentInd-2
Item
Patient has given permission to keep blood sample(s) for use in future research to learn about genetics and how they relate to cancer. This may also include research on inherited traits (genes passed on in families).
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (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)
C17938 (NCI Thesaurus Property-3)
C0314603 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
BloodSpecimenOtherDiseasesandDisordersResearchConsentInd-3
Item
Patient has given permission to keep blood sample(s) for use in future research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include genetic research on inherited traits (genes passed on in families).
boolean
C12434 (NCI Thesaurus ObjectClass)
C0229664 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C0012634 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
PersonSpecimenMalignantNeoplasmFutureClinicalorResearchActivityConsentInd-2
Item
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent, or treat cancer.
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)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16203 (NCI Thesaurus Property-5)
C1516654 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PersonSpecimenMalignantNeoplasmGeneticFutureClinicalorResearchActivityConsentInd-2
Item
Patient has given permission to keep tissue sample(s) for use in future research to learn about genetics and how they relate to cancer. This may also include research on inherited traits (genes passed on in families).
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)
PersonSpecimenFutureUnrelatedClinicalorResearchActivityConsentInd-2
Item
Patient has given permission to keep tissue sample(s) for use in future research to learn about, prevent or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease). This may also include genetic research on inherited traits (genes passed on in families).
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25328 (NCI Thesaurus Property-2)
C0445356 (UMLS 2011AA Property-2)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-3)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-4)
C16203 (NCI Thesaurus Property-5)
C1516654 (UMLS 2011AA Property-5)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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)
CL.24
Code List
Randomization
CL Item
Sublobar Resection With Or Without Brachytherapy (Sublobar resection with or without brachytherapy)
CL Item
Stereotactic Body Radiation Therapy (Stereotactic body radiation therapy)
C15313 (NCI Thesaurus)
C1522449 (UMLS 2011AA)
C0729296 (NCI Metathesaurus)
C13041 (NCI Thesaurus-4)
C1268086 (UMLS 2011AA-5)
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