Patient ID
Item
NCCTG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C25581 (NCI Thesaurus Property)
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)
C0030664 (UMLS 2011AA ObjectClass)
C15896 (NCI Thesaurus ObjectClass)
C1511521 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
PatientInitialsName
Item
Patient Initials
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)
InstitutionIdentifierNumber
Item
Institution Number
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
InstitutionName
Item
Institution
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
DataAmendedInd-3
Item
Are data amended
boolean
C38148 (NCI Thesaurus ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)
C1512699 (UMLS CUI-1)
C1511726 (UMLS CUI-2)
C1691222 (UMLS CUI-3)
RegisteringPersonIdentifierSignatureName
Item
Person Registering
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25645 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus ValueDomain)
C1519316 (UMLS 2011AA ValueDomain)
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)
C1516236 (UMLS 2011AA Property)
InvestigatorSignatureText
Item
Investigator Signature
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
InvestigatorSignatureDate
Item
Date of Investigator Signature
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)
TreatmentArmNumber
Item
Assigned Treatment Arm
text
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C32141 (NCI Thesaurus Property)
C1140618 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C25581 (NCI Thesaurus ObjectClass)
C16112 (NCI Thesaurus Property)
C25532 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C1512693 (UMLS CUI-1)
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)
C25150 (NCI Thesaurus Property)
C0001779 (UMLS CUI-1)
Item
Performance Status
integer
C25664 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1520224 (UMLS CUI-1)
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)
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)
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)
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)
C25460 (NCI Thesaurus Property)
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)
C14173 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
C14173 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
C19157 (NCI Thesaurus ObjectClass)
C17649 (NCI Thesaurus Property)
C15319 (NCI Thesaurus Property)
C2991 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property)
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)
C1512699 (UMLS CUI-1)
C0370003 (UMLS CUI-2)
C1511481 (UMLS CUI-3)