ID

7212

Descrizione

Phase II Breast Cancer - Advanced Disease On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=258957C7-A3E4-6659-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=258957C7-A3E4-6659-E044-0003BA3F9857

Keywords

Klinische Studie [Dokumenttyp]

On-Study Form

C50

19/09/12 19/09/12 -
09/01/15 09/01/15 - Martin Dugas

Caricato su

9 gennaio 2015

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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On-Study - Phase II Breast Cancer - Advanced Disease On-Study Form - 2583382v1.0

model
Dettagli

No Instruction available.

1 moduli

StudyEvent: Phase II Breast Cancer - Advanced Disease On-Study Form
1. No Instruction available.

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

CRF Header

Item Group

Crf Header

Protocol ID Coordinating Group

Item

Coordinating Group Protocol No.

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)

Coordinating Group Code

Item

Coordinating Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C1711341 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25462 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Protocol Title

Item

Protocol Title

text

C25191 (NCI Thesaurus ValueDomain)
C2986303 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C42774 (NCI Thesaurus Property)

Patient Study ID

Item

Patient Study ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25462 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Institution Name

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)
C25191 (NCI Thesaurus ValueDomain)
C21541 (NCI Thesaurus ValueDomain-2)

Registering Group Code

Item

Registering Group Code

text

C25162 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C17005 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)

Registering Institution Code

Item

Registering Institution Code

text

C25162 (NCI Thesaurus ValueDomain)
C1301943 (UMLS CUI-1)
C21541 (NCI Thesaurus ObjectClass)
C0805701 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25645 (NCI Thesaurus ObjectClass-2)

Patient Initials

Item

Patient Initials

text

C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)

Breast: Form Administration

Item Group

Breast: Form Administration

Person Completing Form

Item

Person Completing Form

text

C25191 (NCI Thesaurus ValueDomain)
C1550483 (UMLS CUI-1)
C25657 (NCI Thesaurus ObjectClass)
C25364 (NCI Thesaurus Property)

Data amended

Item

Are data amended? (If data are amended, please circle in red when using paper form)

boolean

C38148 (NCI Thesaurus ValueDomain)
C0680532 (UMLS CUI-1)
C25474 (NCI Thesaurus ObjectClass)
C25416 (NCI Thesaurus Property)

Breast: Patient Characteristics

Item Group

Breast: Patient Characteristics

PatientAgeValue

Item

Patient Age

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)

PatientMenopauseCategory

Item

Menopausal Status

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C3231 (NCI Thesaurus ValueDomain-2)
C0025320 (UMLS 2011AA ValueDomain-2)

CL.2

Code List

Menopausal Status

CL Item

Pre (<6 Mo Since Lmp And No Prior Bilateral Ovariectomy And Not On Estrogen Replacement) (Pre (<6 mo since LMP AND no prior bilateral ovariectomy AND not on estrogen replacement))

CL Item

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy) (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy))

CL Item

Post (prior Bilateral Ovariectomy Or >12 Mo Since Lmp With No Prior Hysterectomy And Not Currently Receiving Therapy With Lh-rh Analogs [e.g., Zoladex]) (Post (prior bilateral ovariectomy OR >12 mo since LMP with no prior hysterectomy AND not currently receiving therapy with LH-RH analogs (e.g., Zoladex)))

HormoneTherapyAdministeredInd-3

Item

Hormone therapy

boolean

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

Breast: Advanced Disease Description

Item Group

Breast: Advanced Disease Description

PrimaryTumorLateralityType

Item

Tumor Laterality (check one)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25251 (NCI Thesaurus ObjectClass-2)
C0205225 (UMLS 2011AA ObjectClass-2)
C25185 (NCI Thesaurus Property)
C0332304 (UMLS 2011AA Property)

CL.4

Code List

Tumor Laterality (check one)

CL Item

Left (Left)

C25229 (NCI Thesaurus)
C0205091 (UMLS 2011AA)

CL Item

Right (Right)

C25228 (NCI Thesaurus)
C0205090 (UMLS 2011AA)

CL Item

Bilateral (Bilateral)

C13332 (NCI Thesaurus)
C0238767 (UMLS 2011AA)

DiseaseFinalDiagnosisHER2/neuType

Item

HER2/neu Final Diagnosis (Primary Tumor)

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25508 (NCI Thesaurus Property-2)
C0205088 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain-2)
C0242957 (UMLS 2011AA ValueDomain-2)

CL.7

Code List

HER2/neu Final Diagnosis (Primary Tumor)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

ERLevelTumorStatus

Item

Receptor Status, ER (Metastatic Tumor)

text

C3262 (NCI Thesaurus ValueDomain)
C0027651 (UMLS 2011AA ValueDomain)
C17069 (NCI Thesaurus ObjectClass)
C0034804 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain-2)
C0449438 (UMLS 2011AA ValueDomain-2)
C25554 (NCI Thesaurus Property)
C0441889 (UMLS 2011AA Property)

CL.9

Code List

Receptor Status, ER (Metastatic Tumor)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

ERLevelTumorStatus

Item

Receptor Status, ER (Metastatic Tumor)

text

CL.9

Code List

Receptor Status, ER (Metastatic Tumor)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

PgRStatusType

Item

Receptor Status, PgR (Metastatic Tumor)

text

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

CL.10

Code List

Receptor Status, PgR (Metastatic Tumor)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

PgRStatusType

Item

Receptor Status, PgR (Metastatic Tumor)

text

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

CL.10

Code List

Receptor Status, PgR (Metastatic Tumor)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

TumorMarkerTestType

Item

Tumor Marker Test Method (Metastatic Tumor)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)

CL.11

Code List

Tumor Marker Test Method (Metastatic Tumor)

CL Item

Immunohistochemistry (ihc) (Immunohistochemistry (IHC))

CL Item

Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))

CL Item

Elisa (ELISA)

C16553 (NCI Thesaurus)
C0014441 (UMLS 2011AA)

CL Item

Other, Specify (Other)

TumorMarkerTestType

Item

Tumor Marker Test Method (Metastatic Tumor)

text

CL.11

Code List

Tumor Marker Test Method (Metastatic Tumor)

CL Item

Immunohistochemistry (ihc) (Immunohistochemistry (IHC))

CL Item

Fluorescence In Situ Hybridization (fish) (Fluorescence in situ hybridization (FISH))

CL Item

Elisa (ELISA)

C16553 (NCI Thesaurus)
C0014441 (UMLS 2011AA)

CL Item

Other, Specify (Other)

TumorMarkerTestSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17220 (NCI Thesaurus ObjectClass)
C0041365 (UMLS 2011AA ObjectClass)

TumorMarkerTestSpecify

Item

Other specify

text

FirstBiopsyPositiveDate

Item

Date of Initial Diagnosis of Primary Tumor

date

C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C25509 (NCI Thesaurus ObjectClass-2)
C1279901 (UMLS 2011AA ObjectClass-2)
C25246 (NCI Thesaurus Property)
C1446409 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

DiseaseRecurrenceDate

Item

Date Progressive or Metastatic Disease First Diagnosed (Unless otherwise specified per protocol, the diagnosis can be radiologically or pathologically measured.)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C3352 (NCI Thesaurus Property)
C0034897 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)

DiseaseProgressionMostRecentDate

Item

Date of Most Recent Progression

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25331 (NCI Thesaurus Property)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

BreastTumorStageGroupingAssessmentType

Item

Stage Grouping Assessment Method (Disease Stage Classification at diagnosis - Indicate highest stage)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38027 (NCI Thesaurus Property-2)
C1519504 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.12

Code List

Stage Grouping Assessment Method (Disease Stage Classification at diagnosis - Indicate highest stage)

CL Item

Clinical (Clinical)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Pathologic (Pathologic)

C25610 (NCI Thesaurus)
C1521733 (UMLS 2011AA)

BreastTumorStageGroupingStage

Item

Stage Grouping

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C38027 (NCI Thesaurus Property)
C1519504 (UMLS 2011AA Property)

CL.13

Code List

Stage Grouping

CL Item

Tis, N0, M0 (0)

CL Item

T1*, N0, M0 (I)

CL Item

T0, N1, M0 Or T1*, N1, M0 Or T2, N0, M0 (IIA)

CL Item

T2, N1, M0 Or T3, N0, M0 (IIB)

CL Item

T0, N2, M0 Or T1*, N2, M0 Or T2, N2, M0 Or T3, N1, M0 Or T3, N2, M0 (IIIA)

CL Item

T4, N0, M0 Or T4, N1, M0 Or T4, N2, M0 (IIIB)

CL Item

Any T, N3, M0 (IIIC)

CL Item

Any T, Any N, M1 (IV)

BreastTumorHistologicGrade

Item

Histologic Grade (For breast cancer, the Nottingham combined histologic grade is recommended)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property-2)
C0678257 (UMLS 2011AA Property-2)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain-2)
C0919553 (UMLS 2011AA ValueDomain-2)

CL.14

Code List

Histologic Grade (For breast cancer, the Nottingham combined histologic grade is recommended)

CL Item

Gx Grade Cannot Be Assessed (GX)

CL Item

G1 Low Combined Histologic Grade (favorable) (G1)

CL Item

G2 Intermediate Combined Histologic Grade (moderately Favorable) (G2)

CL Item

G3 High Combined Histologic Grade (unfavorable) (G3)

Breast: Site(s) of Progression

Item Group

Breast: Site(s) Of Progression

Progression Site

Item

Sites of Progression (check all that apply)

text

C13717 (NCI Thesaurus ValueDomain)
C0242656 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C1515974 (UMLS CUI-2)
C25331 (NCI Thesaurus ObjectClass)

CL.15

Code List

Sites of Progression (check all that apply)

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 tissue)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung, Nos (Lung)

C12468 (NCI Thesaurus)
C0024109 (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 Site(s) (First Other, specify)

CL Item

Other Site(s) (Second Other, specify)

OtherDiseaseSiteName

Item

If sites other than specified, Indicate Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C2991 (NCI Thesaurus ObjectClass-2)
C0012634 (UMLS 2011AA ObjectClass-2)

OtherDiseaseSiteName

Item

If sites other than specified, Indicate Name

text

OrganInvolvedSiteNumber

Item

Total Number of Sites Involved

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property-2)
C13018 (NCI Thesaurus ObjectClass)
C0178784 (UMLS 2011AA ObjectClass)

Breast: Advanced Treatment - Prior Systemic Therapy

Item Group

Breast: Advanced Treatment - Prior Systemic Therapy

AdjuvantHormonalTherapyPriorAdministeredInd-3

Item

Prior Adjuvant Hormonal Therapy? (do not include steroids given with chemotherapy)

boolean

C15445 (NCI Thesaurus ObjectClass)
C0279025 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorHormonalTherapyMetastatic/RecurrentAdministreredInd-3

Item

Prior Hormonal Therapy for Metastasis or Recurrence? (do not include steroids given with chemotherapy)

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus ObjectClass-2)
C0279025 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25567 (NCI Thesaurus Property-2)
C1513186 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

AdjuvantChemotherapyPriorAdministeredInd-3

Item

Prior Adjuvant Chemotherapy? (include pre-op chemotherapy at diagnosis)

boolean

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

PriorChemotherapyMetastatic/RecurrentDiseaseAdministeredInd-3

Item

Prior Chemotherapy for Metastasis or Recurrence?

boolean

C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorHDC/ASCTAdjuvantAdministeredInd-3

Item

Prior Adjuvant High Dose Chemotherapy/Autologous Stem Cell Transplant (HDC/ASCT)

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C38722 (NCI Thesaurus ObjectClass-2)
C1512429 (UMLS 2011AA ObjectClass-2)
C2140 (NCI Thesaurus Property)
C0001552 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorHigh-DoseChemotherapywithStemCellSupportMetastaticRecurrentDiseaseAdministeredInd-3

Item

Prior HDC/ASCT for Metastasis or Recurrence?

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C38722 (NCI Thesaurus ObjectClass-2)
C1512429 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

AdjuvantImmunotherapyPriorAdministeredInd-3

Item

Prior Adjuvant Immunotherapy?

boolean

C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

PriorImmunotherapyMetastaticRecurrentDiseaseAdministeredInd-3

Item

Prior Immunotherapy for Metastasis or Recurrence?

boolean

C15262 (NCI Thesaurus ObjectClass)
C0021083 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

AdjuvantBiologicalTherapyPriorAdministeredInd-3

Item

Prior Adjuvant Biologic Therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15187 (NCI Thesaurus ObjectClass)
C0005527 (UMLS 2011AA ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)

PriorBiologicalTherapyMetastaticAdministeredInd-3

Item

Prior Biologic Thearpy for Metastatic or Recurrence

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15187 (NCI Thesaurus ObjectClass-2)
C0005527 (UMLS 2011AA ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

AdjuvantTherapyOtherAdministeredPriorInd-3

Item

Prior Adjuvant Other Therapy?

boolean

C15368 (NCI Thesaurus ObjectClass)
C2140 (NCI Thesaurus ObjectClass-2)
C0001552 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25629 (NCI Thesaurus ValueDomain-2)
C0332152 (UMLS 2011AA ValueDomain-2)

PriorTherapyMetastaticRecurrentDiseaseAdministeredOtherInd-3

Item

Prior Other Therapy for Metastasis or Recurrence?

boolean

C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C15368 (NCI Thesaurus ObjectClass-2)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C38155 (NCI Thesaurus Property-2)
C0277556 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C38148 (NCI Thesaurus ValueDomain-2)
C1512699 (UMLS 2011AA ValueDomain-2)

Breast: Advanced Prior Treatment

Item Group

Breast: Advanced Prior Treatment - Systemic Regimens

Number of prior therapy regimens

Item

Number of prior therapy regimens

float

C25629 (NCI Thesaurus ObjectClass)
C0750480 (UMLS CUI-1)
C15368 (NCI Thesaurus ObjectClass-2)
C25463 (NCI Thesaurus ValueDomain)
C0040808 (UMLS CUI-2)
C15697 (NCI Thesaurus Property)
C0332152 (UMLS CUI-3)

Agent

Item

Agent Name

text

C25364 (NCI Thesaurus Property)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C1708 (NCI Thesaurus ValueDomain)
C42614 (NCI Thesaurus ValueDomain-2)

Medication Start Date

Item

Agent Start Date

date

C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C25431 (NCI Thesaurus ValueDomain-2)
C0808070 (UMLS CUI-2)
C1708 (NCI Thesaurus ObjectClass)
C25275 (NCI Thesaurus Property)

Medication End Date

Item

Agent End Date

date

C25164 (NCI Thesaurus ValueDomain)
C1521826 (UMLS CUI-1)
C1708 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)

Cumulative Dose Agent

Item

Agent Total Cumulative Dose

float

C1708 (NCI Thesaurus ObjectClass)
C2986497 (UMLS CUI-1)
C25470 (NCI Thesaurus ObjectClass-2)
C1521826 (UMLS CUI-2)
C25304 (NCI Thesaurus Property)
C25256 (NCI Thesaurus Property-2)
C25304 (NCI Thesaurus ValueDomain)
C25488 (NCI Thesaurus ValueDomain-2)

TreatmentCycleCount

Item

No. of Cycles

float

C25472 (NCI Thesaurus Property)
C1511572 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

Overall Response Duration

Item

Overall Response Duration

integer

C25755 (NCI Thesaurus ObjectClass)
C0237585 (UMLS CUI-1)
C25605 (NCI Thesaurus Property)
C25275 (NCI Thesaurus Property-2)
C25605 (NCI Thesaurus ValueDomain)
C25330 (NCI Thesaurus ValueDomain-2)

Breast: Prior Radiation Therapy

Item Group

Lung: Prior Radiation Therapy ¿ Nsclc Advanced

Prior Radiation Therapy

Item

Prior Radiation Therapy

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0332152 (UMLS CUI-2)
C25629 (NCI Thesaurus ObjectClass-2)
C25382 (NCI Thesaurus Property)

PriorRTAdministeredType

Item

Prior Radiation Therapy Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)
C0332152 (UMLS 2011AA ObjectClass-2)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.29

Code List

Prior Radiation Therapy Type

CL Item

Local-regional (Local-Regional)

C25388 (NCI Thesaurus)
C1947913 (UMLS 2011AA)

CL Item

Metastatic (Metastatic)

C14174 (NCI Thesaurus)
C0036525 (UMLS 2011AA)

RTBreastAdministeredTotalDose

Item

Total Dose to Breast (cGy)

float

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus Property)
C0006141 (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)

Radiation Therapy End Date

Item

Radiation Therapy End Date

date

C25164 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0806020 (UMLS CUI-2)
C25275 (NCI Thesaurus Property)
C25496 (NCI Thesaurus Property-2)

Radiation Therapy Type

Item

Type of Radiation Therapy Administered

text

C25284 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C0683312 (UMLS CUI-2)
C25382 (NCI Thesaurus Property)

CL.30

Code List

Type of Radiation Therapy Administered

CL Item

External Beam Radiation (External beam radiation)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)

Radiotherapy type

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C25365 (NCI Thesaurus Property)

Radiation Therapy Body Site

Item

Radiation Therapy Site

text

C25191 (NCI Thesaurus ValueDomain)
C1997599 (UMLS CUI-1)
C25341 (NCI Thesaurus Property)
C15313 (NCI Thesaurus ObjectClass)

Radiation Therapy Dose per Fraction

Item

RT Dose per Fraction (units)

float

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS CUI-1)
C25488 (NCI Thesaurus ValueDomain)
C0178602 (UMLS CUI-2)
C25514 (NCI Thesaurus Property)
C1264633 (UMLS CUI-3)

Units

Item

Units

text

C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)

CL.32

Code List

Units

CL Item

Centigrays (cGy)

CL Item

Millicurie (mCi)

Units

Item

Units

text

C1708 (NCI Thesaurus ObjectClass)
C1519795 (UMLS CUI-1)
C25256 (NCI Thesaurus Property)
C25709 (NCI Thesaurus ValueDomain)

CL.32

Code List

Units

CL Item

Centigrays (cGy)

CL Item

Millicurie (mCi)

Total Number of Fractions

Item

Total Number of Fractions

float

C25304 (NCI Thesaurus Property)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1264633 (UMLS CUI-2)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS CUI-3)
C25514 (NCI Thesaurus Property-2)

Radiation Therapy Total Dose

Item

RT Total Dose (units)

float

C25304 (NCI Thesaurus ValueDomain)
C2169193 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C25488 (NCI Thesaurus ValueDomain-2)
C25382 (NCI Thesaurus Property)

Unscheduled Interruptions in Radiation Therapy

Item

Were there any unscheduled interruptions in radiation therapy?

text

C25180 (NCI Thesaurus ValueDomain)
C1522449 (UMLS CUI-1)
C15313 (NCI Thesaurus ObjectClass)
C1512900 (UMLS CUI-2)
C25542 (NCI Thesaurus Property)

CL.33

Code List

Were there any unscheduled interruptions in radiation therapy?

CL Item

Yes, Due To Toxicity (Yes, due to toxicity)

CL Item

Yes, For Other Reasons, Specify (Yes, for other reasons)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

RadiationTherapyInterruptionReason

Item

RT Interruption Reason (Specify)

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C25542 (NCI Thesaurus Property)
C1512900 (UMLS 2011AA Property)

Breast: Prior Surgery

Item Group

Breast: Prior Surgery

Prior Surgery

Item

Prior Surgery

text

C38148 (NCI Thesaurus ValueDomain)
C0744961 (UMLS CUI-1)
C38000 (NCI Thesaurus Property)
C15329 (NCI Thesaurus ObjectClass)
C25629 (NCI Thesaurus ObjectClass-2)

CL.34

Code List

Prior Surgery

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastPrimarySurgicalProcedurePerformedType

Item

Most Extensive Primary Surgery (check one)

text

C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass-2)
C0006141 (UMLS 2011AA ObjectClass-2)
C15329 (NCI Thesaurus ObjectClass-3)
C0543467 (UMLS 2011AA ObjectClass-3)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.35

Code List

Most Extensive Primary Surgery (check one)

CL Item

Partial Mastectomy, Lumpectomy Or Excisional Biopsy (Partial mastectomy/lumpectomy/excisional biopsy)

CL Item

Mastectomy, Nos (Mastectomy NOS)

PrimarySurgeryDate

Item

Date of Most Extensive Primary Surgery (if required, use last re-excision date)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C25251 (NCI Thesaurus ObjectClass)
C0205225 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass-2)
C0543467 (UMLS 2011AA ObjectClass-2)
C25275 (NCI Thesaurus Property)
C2745955 (UMLS 2011AA Property)

OtherNeoplasmExcisionInd-2

Item

Other tumor excision

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus ObjectClass-2)
C0027651 (UMLS 2011AA ObjectClass-2)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

OtherNeoplasmExcisionSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C3262 (NCI Thesaurus ObjectClass-2)
C0027651 (UMLS 2011AA ObjectClass-2)
C15232 (NCI Thesaurus Property)
C0728940 (UMLS 2011AA Property)

Breast: Prior Surgery

Item Group

Breast: Prior Surgery

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On-Study - Phase II Breast Cancer - Advanced Disease On-Study Form - 2583382v1.0

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