ID

1082

Beschrijving

CALGB_40301_ON_STUDY_FORM Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E53B0CD1-788E-25B9-E034-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=E53B0CD1-788E-25B9-E034-0003BA3F9857

Trefwoorden

C50

Geüploaded op

26 augustus 2012

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer On-Study - CALGB_40301_ON_STUDY_FORM - 2294326v3.0

model
Details

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

1 Formulieren

StudyEvent: CALGB_40301_ON_STUDY_FORM
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Unnamed1

Item Group

Unnamed1

CALGBForm

Item

CALGB Form

text

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed2

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)

PatientHospitalNumber

Item

Patient Hospital No

text

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PATIENT CHARACTERISTICS

Item Group

Patient Characteristics

PatientPostMenopauseIndicator

Item

Post menopausal

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15421 (NCI Thesaurus Property)
C0232970 (UMLS 2011AA Property)

CL.2

Code List

Post menopausal

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

HormoneTherapyGonadotrophinReleasingHormoneAgonistAdministeredInd-3

Item

Is patient on ovarian suppression with GnRH-A angonist

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C2270 (NCI Thesaurus Property)
C0023610 (UMLS 2011AA Property)
C1514 (NCI Thesaurus Property)
C0243192 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.3

Code List

Is patient on ovarian suppression with GnRH-A angonist

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DISEASE DESCRIPTION

Item Group

Disease Description

ERLevelTumorStatus

Item

ER status (Mark one with an X.)

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.4

Code List

ER status (Mark one with an X.)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

ERAssayPerformedTime

Item

Other, specify

text

C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)

PgRStatusType

Item

PgR status (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C0678257 (NCI Metathesaurus Property)

CL.6

Code List

PgR status (Mark one with an X.)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorMarkerVisitCollectedType

Item

Timing of assay (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25452 (NCI Thesaurus ValueDomain)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25716 (NCI Thesaurus Property)
C0545082 (UMLS 2011AA Property)

CL.7

Code List

Timing of assay (Mark one with an X.)

CL Item

Initial Diagnosis (Initial diagnosis)

CL Item

At Recurrence (At recurrence)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TumorMarkerVisitCollectedType

Item

Timing of assay (Mark one with an X.)

text

CL.7

Code List

Timing of assay (Mark one with an X.)

CL Item

Initial Diagnosis (Initial diagnosis)

CL Item

At Recurrence (At recurrence)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

PgRAssayPerformedTime

Item

Other, specify

text

C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25207 (NCI Thesaurus ValueDomain)
C0040223 (UMLS 2011AA ValueDomain)
C17075 (NCI Thesaurus ObjectClass)
C0034833 (UMLS 2011AA ObjectClass)
C16341 (NCI Thesaurus ObjectClass)
C0005507 (UMLS 2011AA ObjectClass)

FirstBiopsyPositiveDate

Item

Date of initial diagnosis of primary tumor

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass)
C1279901 (UMLS 2011AA ObjectClass)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

DiseaseRecurrenceDate

Item

Date progressive or metastatic disease first diagnosed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

Unnamed3

Item Group

Unnamed3

SITE OF PROGRESSION OR RECURRENCE

Item Group

Site Of Progression Or Recurrence

ProgressionSite

Item

Site of progression (s)

text

C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)

CL.8

Code List

Site of progression (s)

CL Item

Local-regional (including Ipsilateral Breast; Chest Wall; Axillary, Internal Mammary, And Infraclavicular Nodes; Local-regional Skin And Subcutaneous Tissue) (Local-regional)

CL Item

Ipsilateral Supraclavicular Nodes (Ipsilateral supraclavicular nodes)

CL Item

Contralateral Breast (Opposite breast)

CL Item

Distant Lymph Nodes (Distant nodes)

CL Item

Distant Skin/subcutaneous Tissue (Distant skin/subcutaneous skin)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Lung, Nos (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Brain (Brain)

C12439 (NCI Thesaurus)
C0006104 (UMLS 2011AA)

CL Item

Other Cns (Other CNS)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

ProgressionSiteSpecify

Item

Other, specify:

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25331 (NCI Thesaurus ObjectClass)

PRIOR SYSTEMIC THERAPY

Item Group

Prior Systemic Therapy

AdjuvantHormonalTherapyPriorAdministeredInd-3

Item

Prior adjuvant hormonal therapy (Do not include steroids given with chemotherapy.)

text

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.9

Code List

Prior adjuvant hormonal therapy (Do not include steroids given with chemotherapy.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorHormonalTherapyMetastatic/RecurrentAdministreredInd-3

Item

Prior endocrine therapy for metastasis or recurrence (Do not include steroids given with chemotherapy.)

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25567 (NCI Thesaurus Property)
C1513186 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.10

Code List

Prior endocrine therapy for metastasis or recurrence (Do not include steroids given with chemotherapy.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorChemotherapyAdministeredInd-3

Item

Prior adjuvant chemotherapy (Include pre-op chemotherapy at diagnosis.)

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.11

Code List

Prior adjuvant chemotherapy (Include pre-op chemotherapy at diagnosis.)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorChemotherapyMetastatic/RecurrentDiseaseAdministeredInd-3

Item

Prior chemotherapy for metastasis or recurrence

text

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.12

Code List

Prior chemotherapy for metastasis or recurrence

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorHDC/ASCTAdjuvantAdministeredInd-3

Item

Prior adjuvant high dose chemotherapy/Autologous stem cell transplant (HDC/ASCT )

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C38722 (NCI Thesaurus ObjectClass)
C1512429 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus Property)
C0001552 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Prior adjuvant high dose chemotherapy/Autologous stem cell transplant (HDC/ASCT )

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorHigh-DoseChemotherapywithStemCellSupportMetastaticRecurrentDiseaseAdministeredInd-3

Item

Prior HDC/ASCT for metastasis or recurrence

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C38722 (NCI Thesaurus ObjectClass)
C1512429 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.14

Code List

Prior HDC/ASCT for metastasis or recurrence

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AdjuvantImmunotherapyPriorAdministeredInd-3

Item

Prior adjuvant immunotherapy

text

C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.15

Code List

Prior adjuvant immunotherapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorImmunotherapyMetastaticRecurrentDiseaseAdministeredInd-3

Item

Prior immunotherapy for metastasis or recurrence

text

C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.16

Code List

Prior immunotherapy for metastasis or recurrence

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AdjuvantTherapyOtherAdministeredPriorInd-3

Item

Prior adjuvant other therapy

text

C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ValueDomain)
C0332152 (UMLS 2011AA ValueDomain)

CL.17

Code List

Prior adjuvant other therapy

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AdjuvantTherapyOtherAdministeredSpecify

Item

Yes, specify (If)

text

C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass)
C0001552 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PriorTherapyMetastaticRecurrentDiseaseAdministeredOtherInd-3

Item

Prior other therapy for metastasis or recurrence

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.18

Code List

Prior other therapy for metastasis or recurrence

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PriorTherapyMetastaticRecurrentDiseaseAdministeredSpecify

Item

Yes, specify (If)

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

PRIOR SYSTEMIC REGIMENS

Item Group

Prior Systemic Regimens

PriorTreatmentRegimenName

Item

Prior treatment regimen name (s)

text

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C42614 (NCI Thesaurus ValueDomain)
C0027365 (UMLS 2011AA ValueDomain)

PriorTreatmentRegimenBeginDate

Item

Start date

date

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

PriorTreatmentRegimenEndDate

Item

End date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

PriorTreatmentRegimenType

Item

Prior treatment regimen type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C15697 (NCI Thesaurus Property)
C0040808 (UMLS 2011AA Property)

CL.19

Code List

Prior treatment regimen type

CL Item

Adjuvant (Adjuvant)

C25722 (NCI Thesaurus)
C1522673 (UMLS 2011AA)

CL Item

Advanced (Advanced)

C25411 (NCI Thesaurus)
C0205179 (UMLS 2011AA)

REQUIRED LABORATORY VALUES

Item Group

Required Laboratory Values

LaboratoryProcedureGranulocyteResultCount

Item

Granulocytes

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property)
C0018183 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

LaboratoryProcedurePlateletResultSpecifiedValue

Item

Platelet count

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12520 (NCI Thesaurus Property)
C0005821 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

RenalCreatinineLabSpecifiedValue

Item

Creatinine

double

C25225 (NCI Thesaurus ObjectClass)
C0022646 (UMLS 2011AA ObjectClass)
C399 (NCI Thesaurus Property)
C0010294 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

HepaticBilirubinLabValue

Item

Bilirubin

double

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

HepaticBilirubinLabUpperLimitNormalValue

Item

Bilirubin ULN

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C305 (NCI Thesaurus Property)
C0005437 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultStatus

Item

ALT

text

C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicPyruvicTransaminaseResultUpperLimitofNormalValue

Item

ALT ULN

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25293 (NCI Thesaurus Property)
C0376147 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

HepaticSGOT(AST)LabUnspecifiedValue

Item

AST

double

C13308 (NCI Thesaurus ObjectClass)
C0205054 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C38046 (NCI Thesaurus ValueDomain)
C0205370 (UMLS 2011AA ValueDomain)
C37984 (NCI Thesaurus Property)
C0022877 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

LaboratoryProcedureSerumGlutamicOxaloaceticTransferaseResultUnspecifiedUpperLimitofNormalValue

Item

AST ULN

double

C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25202 (NCI Thesaurus Property)
C0242192 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25706 (NCI Thesaurus ValueDomain)
C1519815 (UMLS 2011AA ValueDomain)

TumorMarkerAvailableAssessmentType

Item

Was tumor marker information available for the following (Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25429 (NCI Thesaurus Property)
C0470187 (UMLS 2011AA Property)

CL.20

Code List

Was tumor marker information available for the following (Mark all that apply with an X.)

CL Item

Cea (CEA)

CL Item

Ca 15-3 (CA 15-5)

CL Item

Ca 27-29 (CA 27-29)

TumorMarkerCEATestValue

Item

CEA, specify value

text

C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

TumorMarkerCA15-3TestValue

Item

CA 15-5, specify value

text

C25294 (NCI Thesaurus ValueDomain)
C0022885 (UMLS 2011AA ValueDomain)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
CL122032 (NCI Metathesaurus Property)

TumorMarkerCA27-29TestValue

Item

CA 27-29, specify value

text

C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C0291672 (NCI Metathesaurus Property)

ResponsiblePersonName

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormCompleteDate

Item

Date form completed

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C40988 (NCI Thesaurus ObjectClass)
C1516308 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

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Breast Cancer On-Study - CALGB_40301_ON_STUDY_FORM - 2294326v3.0

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted. For optimal accuracy use black ink.

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