ID

9374

Description

NCCTG Pre-Registration Eligibility Checklist - Central Pathology Review Form ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=36179FE2-B4A6-4988-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=36179FE2-B4A6-4988-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 12/18/14 12/18/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
Uploaded on

January 9, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Central Pathology Review Form (NCCTG Pre-Registration Eligibility Checklist)

English

No Instruction available.

1 forms  
  1. StudyEvent: NCCTG Pre-Registration Eligibility Checklist - Central Pathology Review Form
    1. No Instruction available.
Header Module
Description

Header Module

Alias
UMLS CUI-1
C1320722
NCCTG Study No.
Description

ProtocolNorthCentralCancerTreatmentGroupIdentifierNumber

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C25320
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25581
UMLS CUI-1
C1549740
UMLS CUI-2
C1518419
Central Lab ID Number
Description

PathologyCoreFacilityLaboratoryIdentifierNumber

Data type

text

Alias
NCI Thesaurus ObjectClass
C37984
UMLS 2011AA ObjectClass
C0022877
NCI Thesaurus ObjectClass-2
C18189
UMLS 2011AA ObjectClass-2
C0030664
NCI Thesaurus ObjectClass-3
C15896
UMLS 2011AA ObjectClass-3
C1511521
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
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 Number
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
Institution
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
Are data amended
Description

DataAmendedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus ObjectClass
C25474
NCI Thesaurus Property
C25416
UMLS CUI-1
C0680532
Person Registering
Description

RegisteringPersonIdentifierSignatureName

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus ObjectClass-2
C25645
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ValueDomain-2
C25678
UMLS 2011AA ValueDomain-2
C1519316
CTSU Random. specialist
Description

PersonCancerTrialsSupportUnitRandomizationName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25196
UMLS 2011AA Property
C0034656
NCI Thesaurus Property-2
C20090
UMLS 2011AA Property-2
C1516236
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
NCI Thesaurus ObjectClass
C17089
Date of Investigator Signature
Description

Investigator Signature Date

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS CUI-1
C2346576
NCI Thesaurus Property
C25678
UMLS CUI-2
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C17089
I. Snap Frozen Tissue
Description

I. Snap Frozen Tissue

Assigned Treatment Arm
Description

Protocol Treatment Arm

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1522541
NCI Thesaurus Property
C32141
NCI Thesaurus ObjectClass
C15368
Inclusion Criteria
Description

NCCTGPatientN063DInclusionClinicalTrialEligibilityCriteriaCentralPathologyReviewType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ObjectClass-2
C25581
NCI Thesaurus Property
C16112
NCI Thesaurus Property-2
C25532
NCI Thesaurus ValueDomain
C25284
UMLS CUI-1
C1512693
Age
Description

PatientAgeYearCount

Data type

integer

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus ValueDomain
C29848
NCI Thesaurus ValueDomain-2
C25463
NCI Thesaurus Property
C25150
UMLS CUI-1
C0001779
Performance Status
Description

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25664
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
UMLS CUI-1
C1520224
Authorization for use and disclosure of protected health information signed and dated
Description

PatientHealthRecordIndicator

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C25180
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25178
UMLS CUI-1
C1522602
UMLS CUI-2
C0030705
UMLS CUI-3
C0018684
Date of authorization
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
Patient has consented to take part in the Quality of Life Study
Description

PatientQualityofLifeConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus Property
C17047
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property-2
C25460
UMLS CUI-1
C1512698
UMLS CUI-2
C0518214
UMLS CUI-3
C0030705
UMLS CUI-4
C1511481
Patient has given permission for pharmacogenetic testing on her/his blood samples
Description

PatientBloodSpecimenConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C12434
NCI Thesaurus Property-2
C19157
NCI Thesaurus Property-3
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0030705
UMLS CUI-2
C0229664
UMLS CUI-3
C0370003
UMLS CUI-4
C1511481
UMLS CUI-5
C1512698
Patient has given permission for pharmacogenetic testing on her/his tissue samples
Description

PatientTissueBankingConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25460
NCI Metathesaurus Property
C0087095
UMLS CUI-1
C1512698
UMLS CUI-2
C0030705
UMLS CUI-3
C1511481
Patient has consented provide recurrence blood (if available) samples
Description

BloodSpecimenRecurrentDiseaseorDisorderConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12434
NCI Thesaurus ObjectClass-2
C19157
NCI Thesaurus Property
C14173
NCI Thesaurus Property-2
C2991
NCI Thesaurus Property-3
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0229664
UMLS CUI-2
C0370003
UMLS CUI-3
C2945760
UMLS CUI-4
C0012634
UMLS CUI-5
C1511481
UMLS CUI-6
C1512698
Patient has consented to provide recurrence tissue (if available) samples
Description

TissueSpecimenRecurrentDiseaseorDisorderConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
NCI Thesaurus ObjectClass-2
C19157
NCI Thesaurus Property
C14173
NCI Thesaurus Property-2
C2991
NCI Thesaurus Property-3
C25460
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0040300
UMLS CUI-2
C0370003
UMLS CUI-3
C2945760
UMLS CUI-4
C0012634
UMLS CUI-5
C1511481
UMLS CUI-6
C1512698
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
Description

BloodTissueSpecimenOtherDiseasesandDisordersResearchConsentInd-3

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C12801
NCI Thesaurus ObjectClass-2
C12434
NCI Thesaurus ObjectClass-3
C19157
NCI Thesaurus Property
C17649
NCI Thesaurus Property-2
C15319
NCI Thesaurus Property-3
C2991
NCI Thesaurus Property-4
C25460
NCI Thesaurus ValueDomain
C38148
Patient's initial consent for sharing specimen(s) with outside researchers.
Description

SpecimenResearchConsentSharedInd-3

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38148
NCI Thesaurus Property
C15319
NCI Thesaurus ObjectClass
C19157
NCI Thesaurus Property-2
C25460
UMLS CUI-1
C1512699
UMLS CUI-2
C0370003
UMLS CUI-3
C1511481
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1 forms
  1. StudyEvent: NCCTG Pre-Registration Eligibility Checklist - Central Pathology Review Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header Module
C1320722 (UMLS CUI-1)
Patient ID
Item
NCCTG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25581 (NCI Thesaurus Property-2)
C1549740 (UMLS CUI-1)
C1518419 (UMLS CUI-2)
PathologyCoreFacilityLaboratoryIdentifierNumber
Item
Central Lab ID Number
text
C37984 (NCI Thesaurus ObjectClass)
C0022877 (UMLS 2011AA ObjectClass)
C18189 (NCI Thesaurus ObjectClass-2)
C0030664 (UMLS 2011AA ObjectClass-2)
C15896 (NCI Thesaurus ObjectClass-3)
C1511521 (UMLS 2011AA ObjectClass-3)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Institution Number
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
Institution Name
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C21541 (NCI Thesaurus ValueDomain-2)
C25364 (NCI Thesaurus Property)
Data amended
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C0680532 (UMLS CUI-1)
RegisteringPersonIdentifierSignatureName
Item
Person Registering
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus ValueDomain-2)
C1519316 (UMLS 2011AA ValueDomain-2)
PersonCancerTrialsSupportUnitRandomizationName
Item
CTSU Random. specialist
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25196 (NCI Thesaurus Property)
C0034656 (UMLS 2011AA Property)
C20090 (NCI Thesaurus Property-2)
C1516236 (UMLS 2011AA Property-2)
Investigator Signature
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
Investigator Signature Date
Item
Date of Investigator Signature
date
C25164 (NCI Thesaurus ValueDomain)
C2346576 (UMLS CUI-1)
C25678 (NCI Thesaurus Property)
C0011008 (UMLS CUI-2)
C25367 (NCI Thesaurus ValueDomain-2)
C17089 (NCI Thesaurus ObjectClass)
Item Group
I. Snap Frozen Tissue
Protocol Treatment Arm
Item
Assigned Treatment Arm
text
C25337 (NCI Thesaurus ValueDomain)
C1522541 (UMLS CUI-1)
C32141 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C25581 (NCI Thesaurus ObjectClass-2)
C16112 (NCI Thesaurus Property)
C25532 (NCI Thesaurus Property-2)
C25284 (NCI Thesaurus ValueDomain)
C1512693 (UMLS CUI-1)
CL.2
Code List
Inclusion Criteria
CL Item
Non-metastatic Operable Primary Invasive Adenocarcinoma Of The Breast (Non-metastatic operable primary invasive adenocarcinoma of the breast)
CL Item
Histologically Confirmed (Histologically confirmed)
CL Item
Adequately Excised (Adequately excised)
CL Item
Axilla Dissected (Axilla dissected)
CL Item
Known Hormone Receptor Status (er/pgr Or Er Alone) (Known hormone receptor status (ER/PgR or ER alone))
CL Item
Overexpression And/or Amplification Of Her2 In The Invasive Component Of The Primary Tumor (Overexpression and/or amplification of HER2 in the invasive component of the primary tumor)
CL Item
Informed Consent Has Been Signed And Dated By The Patient And Person Obtaining Consent (Informed Consent has been signed and dated by the patient and person obtaining consent)
CL Item
Tissue Portion Of The Consent Form Is Complete (Tissue portion of the consent form is complete)
CL Item
Irb Approval At The Registering Institution (IRB approval at the registering institution)
CL Item
Existence Of A Signed Consent Form (Existence of a signed consent form)
CL Item
Patient Has Agreed By Signature Of Consent Form To Allow Tissue And Blood Samples To Be Used For Correlative Science Studies Associated With This Study (Patient has agreed by signature of consent form to allow tissue and blood samples to be used for correlative science studies associated with this study)
CL Item
Patient Registered In The Mandatory Translational Research Component Of This Study At The Time Of Pre-registration (Patient registered in the mandatory translational research component of this study at the time of pre-registration)
CL Item
Blood Draw Kit Availability Checked (Blood draw kit availability checked)
CL Item
Patient Questionnaire Booklet Availability Checked (Patient Questionnaire booklet availability checked)
CL Item
18 years of age, diagnosed with primary, invasive breast cancer (Woman or man >)
CL Item
1 (Eastern Cooperative Oncology Group (ECOG) performance status <)
CL Item
T1c) according to TNM (Axillary node positive patient OR node negative patient with a tumour greater than or equal to 1.0 cm in greatest diameter (>)
Age
Item
Age
integer
C16960 (NCI Thesaurus ObjectClass)
C29848 (NCI Thesaurus ValueDomain)
C25463 (NCI Thesaurus ValueDomain-2)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI-1)
Item
Performance Status
integer
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
CL.3
Code List
Performance Status
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)
CL Item
Dead (5)
PatientHealthRecordIndicator
Item
Authorization for use and disclosure of protected health information signed and dated
boolean
C25180 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25178 (NCI Thesaurus Property)
C1522602 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C0018684 (UMLS CUI-3)
PatientSignedDischargeMedicalRecordDate
Item
Date of authorization
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)
PatientQualityofLifeConsentInd-2
Item
Patient has consented to take part in the Quality of Life Study
boolean
C38147 (NCI Thesaurus ValueDomain)
C17047 (NCI Thesaurus Property)
C16960 (NCI Thesaurus ObjectClass)
C25460 (NCI Thesaurus Property-2)
C1512698 (UMLS CUI-1)
C0518214 (UMLS CUI-2)
C0030705 (UMLS CUI-3)
C1511481 (UMLS CUI-4)
PatientBloodSpecimenConsentInd-2
Item
Patient has given permission for pharmacogenetic testing on her/his blood samples
boolean
C16960 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus Property)
C19157 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0030705 (UMLS CUI-1)
C0229664 (UMLS CUI-2)
C0370003 (UMLS CUI-3)
C1511481 (UMLS CUI-4)
C1512698 (UMLS CUI-5)
PatientTissueBankingConsentInd-2
Item
Patient has given permission for pharmacogenetic testing on her/his tissue samples
boolean
C38147 (NCI Thesaurus ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C25460 (NCI Thesaurus Property)
C0087095 (NCI Metathesaurus Property)
C1512698 (UMLS CUI-1)
C0030705 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
BloodSpecimenRecurrentDiseaseorDisorderConsentInd-2
Item
Patient has consented provide recurrence blood (if available) samples
boolean
C12434 (NCI Thesaurus ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C14173 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0229664 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C2945760 (UMLS CUI-3)
C0012634 (UMLS CUI-4)
C1511481 (UMLS CUI-5)
C1512698 (UMLS CUI-6)
TissueSpecimenRecurrentDiseaseorDisorderConsentInd-2
Item
Patient has consented to provide recurrence tissue (if available) samples
boolean
C12801 (NCI Thesaurus ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C14173 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property-2)
C25460 (NCI Thesaurus Property-3)
C38147 (NCI Thesaurus ValueDomain)
C0040300 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C2945760 (UMLS CUI-3)
C0012634 (UMLS CUI-4)
C1511481 (UMLS CUI-5)
C1512698 (UMLS CUI-6)
Consent for specimen use in research
Item
Patient's Initial Consent given for specimen use for research unrelated to the patient's cancer?
boolean
C12801 (NCI Thesaurus ObjectClass)
C12434 (NCI Thesaurus ObjectClass-2)
C19157 (NCI Thesaurus ObjectClass-3)
C17649 (NCI Thesaurus Property)
C15319 (NCI Thesaurus Property-2)
C2991 (NCI Thesaurus Property-3)
C25460 (NCI Thesaurus Property-4)
C38148 (NCI Thesaurus ValueDomain)
SpecimenResearchConsentSharedInd-3
Item
Patient's initial consent for sharing specimen(s) with outside researchers.
boolean
C38148 (NCI Thesaurus ValueDomain)
C15319 (NCI Thesaurus Property)
C19157 (NCI Thesaurus ObjectClass)
C25460 (NCI Thesaurus Property-2)
C1512699 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)
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