ID

1118

Description

CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW FORM Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A58BBD2-8485-72B0-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A58BBD2-8485-72B0-E044-0003BA3F9857

Keywords

Breast Neoplasms

Uploaded on

August 27, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00770809 Treatment - CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW FORM - 2682513v1.0

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 forms

StudyEvent: CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW 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)

Data type

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

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)

TreatmentReportingPeriodEndDate

Item

Reporting Period End Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property)
C0700287 (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)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

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)

SPECIMEN DETAILS

Item Group

Specimen Details

SpecimenCollectedSubmissionType

Item

Breast Specimen

text

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ValueDomain)
C0370003 (UMLS 2011AA ValueDomain)
C25695 (NCI Thesaurus ValueDomain)
C1515023 (UMLS 2011AA ValueDomain)

CL.2

Code List

Breast Specimen

CL Item

Main Specimen With Separately Submitted Margins (Main specimen with separately submitted margins)

CL Item

Single Specimen (Single specimen)

SurgicalProcedureBreastNeoplasmPerformedType

Item

Type

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C2910 (NCI Thesaurus Property)
C0042875 (UMLS 2011AA Property)

CL.3

Code List

Type

CL Item

Lumpectomy (Lumpectomy)

C15755 (NCI Thesaurus)
C0024885 (UMLS 2011AA)

CL Item

Mastectomy (Mastectomy)

C15277 (NCI Thesaurus)
C0024881 (UMLS 2011AA)

SpecimenSliceCount

Item

Total number of specimen slices

double

C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25682 (NCI Thesaurus Property)
C1519355 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ValueDomain)
C0370003 (UMLS 2011AA ValueDomain)
C25682 (NCI Thesaurus ValueDomain)
C1519355 (UMLS 2011AA ValueDomain)

TumorLargestDimensionMeasurement

Item

Dimension 1

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25550 (NCI Thesaurus Property)
C0443228 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

TumorSecondDimensionMeasurement

Item

Dimension 2

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25666 (NCI Thesaurus Property)
C0205436 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

TumorThirdDimensionMeasurement

Item

Dimension 3

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25260 (NCI Thesaurus Property)
C0205437 (UMLS 2011AA Property)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)

BreastCarcinomaSpecimenSubmittedHistologyIndicator

Item

Main specimen entirely submitted for histology?

text

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16681 (NCI Thesaurus ValueDomain)
C0019638 (UMLS 2011AA ValueDomain)
C25695 (NCI Thesaurus ValueDomain)
C1515023 (UMLS 2011AA ValueDomain)

CL.4

Code List

Main specimen entirely submitted for histology?

CL Item

No: C49487 (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes: C49488 (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

GROSS FINDINGS

Item Group

Gross Findings

GrossTumorResidualPathologyType

Item

Gross pathology present? (Mark all that apply)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C43566 (NCI Thesaurus ObjectClass)
C0439806 (UMLS 2011AA ObjectClass)
C37895 (NCI Thesaurus Property)
C1609982 (UMLS 2011AA Property)
C25649 (NCI Thesaurus Property)
C1527428 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C18189 (NCI Thesaurus ValueDomain)
C0030664 (UMLS 2011AA ValueDomain)
C43566 (NCI Thesaurus ValueDomain)
C0439806 (UMLS 2011AA ValueDomain)

CL.5

Code List

Gross pathology present? (Mark all that apply)

CL Item

Gross Stromal Alterations/fibrosis (Gross stromal alterations/fibrosis)

CL Item

Multifocal Discrete Masses (Multifocal discrete masses)

CL Item

None Present (None present)

CL Item

Single Discrete Mass (Single discrete mass)

HISTOLOGIC FINDINGS

Item Group

Histologic Findings

InvasiveBreastCarcinomaPresentStatus

Item

Invasive cancer

text

C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9245 (NCI Thesaurus ObjectClass)
C0853879 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.6

Code List

Invasive cancer

CL Item

Not Present (Not present)

C1549059 (NCI Metathesaurus)

CL Item

Present (Present)

C25626 (NCI Thesaurus)
C0150312 (UMLS 2011AA)

InvasiveBreastCarcinomaPresentType

Item

Size

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C9245 (NCI Thesaurus ObjectClass)
C0853879 (UMLS 2011AA ObjectClass)

CL.7

Code List

Size

CL Item

Microscopic Foci Of Invasive Carcinoma (<0.2 Mm) Only (Microscopic foci of invasive carcinoma (<0.2 mm) only)

CL Item

Microscopic Foci Of Invasive Carcinoma (>0.2-2 Mm) Only (Microscopic foci of invasive carcinoma (>0.2-2 mm) only)

CL Item

Multifocal (Multifocal)

C25253 (NCI Thesaurus)
C0205292 (UMLS 2011AA)

CL Item

Single Discrete Mass Present (Single discrete mass present)

SpecimenSliceCount

Item

Total number of specimen slices

double

TumorLargestDimensionMeasurement

Item

Dimension 1

double

TumorSecondDimensionMeasurement

Item

Dimension 2

double

TumorThirdDimensionMeasurement

Item

Dimension 3

double

InvasiveBreastCarcinomaExtentNumber

Item

Cellularity of invasive cancer

double

C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C25458 (NCI Thesaurus Property)
C0750484 (UMLS 2011AA Property)
C25527 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)

BreastTumorHistologicCategory

Item

Histologic Type

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.8

Code List

Histologic Type

CL Item

Ductal (Ductal)

C25732 (NCI Thesaurus)
C1512083 (UMLS 2011AA)

CL Item

Lobular (Lobular)

C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)
C25557 (NCI Thesaurus)
C0205417 (UMLS 2011AA)

CL Item

Mixed Ductal And Lobular (Mixed ductal and lobular)

CL Item

Other Specify (Other)

DuctalTumorHistologicCategorySpecify

Item

Other, specify

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25732 (NCI Thesaurus ObjectClass)
C1512083 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

BreastNeoplasmNuclearGradeCategory

Item

Nuclear Grade

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)

CL.9

Code List

Nuclear Grade

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

MitoticCountScore

Item

Mitotic score

double

C25162 (NCI Thesaurus ValueDomain)
C0805701 (UMLS 2011AA ValueDomain)

CL.10

Code List

Mitotic score

CL Item

<7 Per 1040x Hpf (1)

CL Item

7-14 Mitoses Per 1040x Hpf (2)

CL Item

>14 Per 1040x Hpf (3)

HistologicNottinghamScoreTubulinFormationType

Item

Tubule Formation

text

C25526 (NCI Thesaurus ObjectClass)
C0205462 (UMLS 2011AA ObjectClass)
C25595 (NCI Thesaurus ObjectClass)
C1527124 (UMLS 2011AA ObjectClass)
C17219 (NCI Thesaurus Property)
C0041348 (UMLS 2011AA Property)
C25513 (NCI Thesaurus Property)
C1522492 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.11

Code List

Tubule Formation

CL Item

Indeterminate (Indeterminate)

C48658 (NCI Thesaurus)
C0205258 (UMLS 2011AA)

CL Item

Majority Of Tumor, >75% (1 Pt) (Majority of tumor, >75%)

CL Item

Minimal, < 10% (3 Pt) (Minimal, <10%)

CL Item

Moderate, 10% To 75 % (2 Pt) (Moderate, 10% to 75%)

BreastCarcinomaCombinedHistologicGradeCategory

Item

Histologic Grade

text

C25454 (NCI Thesaurus Property)
C0205195 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C4872 (NCI Thesaurus ObjectClass)
C0678222 (UMLS 2011AA ObjectClass)
C18000 (NCI Thesaurus Property)
C0919553 (UMLS 2011AA Property)

CL.12

Code List

Histologic Grade

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

TumorLymphovascularInvasionInd

Item

Lymphovascular Invasion

text

C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C20625 (NCI Thesaurus Property)
C1269955 (UMLS 2011AA Property)
C25561 (NCI Thesaurus Property)
C1518090 (UMLS 2011AA Property)

CL.13

Code List

Lymphovascular Invasion

CL Item

No (NO)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (YES)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

MARGINS

Item Group

Margins

SurgicalMarginInvolvedInd-3

Item

Does the tumor involve the surgical margin

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25698 (NCI Thesaurus ObjectClass)
C25547 (NCI Thesaurus Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)

CL.14

Code List

Does the tumor involve the surgical margin

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)

MalignantNeoplasmSurgicalMarginDistanceValue

Item

Tumor distance from margin

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C41227 (NCI Thesaurus Property)
C0229985 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)

CL.15

Code List

Tumor distance from margin

CL Item

<= 1mm (<= 1mm)

CL Item

> 1mm (> 1mm)

DCIS

Item Group

Dcis

DCISDiagnosisInd-3

Item

Is DCIS present?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

CL.16

Code List

Is DCIS present?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

DCISDiagnosisCellPercentage

Item

DCIS % (of overall tumor)

double

C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

DCISSpecimenHistologicSpanMeasurement

Item

Total histologic span of DCIS (cm)

double

C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C37990 (NCI Thesaurus ValueDomain)
C48929 (NCI Thesaurus ValueDomain)
C1711300 (UMLS 2011AA ValueDomain)

SpecimenSlideDuctalBreastCarcinomainSituPresentCount

Item

Number of slides with DCIS

double

C25325 (NCI Thesaurus ObjectClass)
C0444330 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C2924 (NCI Thesaurus Property)
C0007124 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

SpecimenSlideDuctalBreastCarcinomainSituExaminedCount

Item

Total number of slides

double

C25325 (NCI Thesaurus ObjectClass)
C0444330 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C2924 (NCI Thesaurus Property)
C0007124 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

DuctalBreastCarcinomainSituHistologicType

Item

Histologic type of DCIS

text

C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ValueDomain)
C0007124 (UMLS 2011AA ValueDomain)

CL.17

Code List

Histologic type of DCIS

CL Item

Apocrine Dcis (Apocrine)

CL Item

Calcifications (Calcifications)

CL Item

Clinging Dcis (Clinging)

CL Item

Cribiform Dcis (Cribiform)

CL Item

Intracystic Dcis (Intracystic)

CL Item

Micropapillary Dcis (Micropapillary)

CL Item

Necrosis (Necrosis)

C16897 (NCI Thesaurus)
C0027540 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Papillary Carcinoma In Situ (Papillary carcinoma in situ)

CL Item

Solid Dcis (Solid)

OtherDuctalBreastCarcinomainSituHistologyText

Item

Other:

text

C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C14159 (NCI Thesaurus ObjectClass)
C0205281 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)
C16681 (NCI Thesaurus ValueDomain)
C0019638 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ValueDomain)
C0007124 (UMLS 2011AA ValueDomain)

BreastCarcinomainSituNuclearGradeCategory

Item

Nuclear Grade of DCIS

text

C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C2924 (NCI Thesaurus ObjectClass)
C0007124 (UMLS 2011AA ObjectClass)
C13361 (NCI Thesaurus Property)
C0521447 (UMLS 2011AA Property)
C48309 (NCI Thesaurus Property)
C0441800 (UMLS 2011AA Property)

CL.18

Code List

Nuclear Grade of DCIS

CL Item

High (High)

C25227 (NCI Thesaurus)
C0205250 (UMLS 2011AA)

CL Item

Intermediate (Intermediate)

C0205103 (NCI Metathesaurus)

CL Item

Low (Low)

CL124342 (NCI Metathesaurus)

LYMPH NODES

Item Group

Lymph Nodes

SentinelNodeBiopsyInd-3

Item

Was sentinel node sampling performed

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

CL.19

Code List

Was sentinel node sampling performed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SentinelNodePositiveAssessmentCount

Item

Number of Positive Sentinel Nodes

double

C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C0205159 (NCI Metathesaurus Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelNodeExaminedCount

Item

Number of Sentinel Nodes Examined

double

C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

AxillaryNodeDissectionInd-3

Item

Was axillary dissection performed?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)

CL.20

Code List

Was axillary dissection performed?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

AxillaryNodeExaminedTotalCount

Item

Number of axillary nodes examined

double

C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)

PositiveAxillaryNodeExaminedTotalCount

Item

Number of positive axillary lymph nodes

double

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25500 (NCI Thesaurus Property)
C0332128 (UMLS 2011AA Property)
C25304 (NCI Thesaurus ValueDomain)
C0439810 (UMLS 2011AA ValueDomain)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)

AxillarySentinelLymphNodeLongestMetastaticDiameterMeasurement

Item

Diameter of largest positive LN metastasis (ALN or SLN) (cm)

double

C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)
C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)

DISEASE STAGING

Item Group

Disease Staging

BreastTumorPostNeoadjuvantTherapyPathologyTStage

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property)
C0030664 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.21

Code List

Pathologic T Stage

CL Item

No Evidence Of Primary Tumor (yT0)

CL Item

Tumor 2 Cm Or Less In Greatest Dimension (yT1)

CL Item

Microinvasion 0.1 Cm Or Less In Greatest Dimension (yT1mic)

CL Item

Tumor More Than 2 Cm But Not More Than 5 Cm In Greatest Dimension (yT2)

CL Item

Tumor More Than 5 Cm In Greatest Dimension (yT3)

CL Item

Tumor Of Any Size With Direct (yT4)

CL Item

Carcinoma In Situ: Intraductal Carcinoma, Lobular Carcinoma In Situ, Or Paget's Disease Of The Nipple With No Tumor (yTis)

CL Item

Primary Tumor Cannot Be Assessed (yTX)

BreastTumorPostNeoadjuvantTherapyPathologyNStage

Item

Pathologic N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property)
C0030664 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.22

Code List

Pathologic N Stage

CL Item

No Regional Lymph Node Metastasis Histologically, No Additional Examination For Isolated Tumor Cells (itc) (ypN0)

CL Item

No Regional Lymph Node Metastasis Histologically, Positive Ihc, No Ihc Cluster >0.2 Mm (ypN0(i+))

CL Item

Metastasis In 1 To 3 Axillary Lymph Nodes, And/or In Internal Mammary Nodes With Microscopic Disease Detected By Sln Dissection But Not Clinically Apparent (ypN1)

CL Item

Metastasis In 4 To 9 Axillary Lymph Nodes, Or In Clinically Apparent ** Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed To Each Other Or To Other Structures (ypN2)

CL Item

Metastasis In Clinically Apparent* Internal Mammary Lymph Nodes In The Absence Of Axillary Lymph Node Metastasis (ypN2b)

CL Item

Metastasis In >= Axillary Lymph Nodes, Or In Infraclavicular Lymph Nodes, Or In Clinically Apparent* Ipsilateral Internal Mammary Lymph Node(s) In The Presence Of 1 Or More Positive Axillary Lymph Node(s); Or, In >3 Axillary Lymph Nodes With Clinically N (ypN3)

CL Item

Regional Lymph Nodes Cannot Be Assessed (e.g., Not Removed For Pathologic Study Or Previously Removed) (ypNX)

BreastTumorPostNeoadjuvantTherapyPathologyMStage

Item

Pathologic M Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C18189 (NCI Thesaurus Property)
C0030664 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.23

Code List

Pathologic M Stage

CL Item

No Distant Metastasis (yM0)

CL Item

Distant Metastasis (yM1)

C18206 (NCI Thesaurus)
C1269798 (UMLS 2011AA)

CL Item

Distant Metastasis Cannot Be Assessed (yMX)

BreastTumorStageGroupingStage

Item

Stage

text

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

CL.24

Code List

Stage

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)

BreastTumorT4StageFindingStatus

Item

Final status of T4 tumor (If patient diagnosed with T4 at baseline, indicate)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25728 (NCI Thesaurus Property)
C0475455 (UMLS 2011AA Property)
C48732 (NCI Thesaurus ValueDomain)
C0475751 (UMLS 2011AA ValueDomain)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.25

Code List

Final status of T4 tumor (If patient diagnosed with T4 at baseline, indicate)

CL Item

Chest Wall Only (Chest wall only)

CL Item

Inflammatory Disease (Inflammatory)

CL Item

Skin And Chest Wall (Skin and chest wall)

CL Item

Skin Only (Skin only)

COMMENTS

Item Group

Comments

ResearchCommentsText

Item

COMMENTS

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)

ResponsiblePersonName

Item

Completed by (Last name, First name)

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 (MM DD YYYY)

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 NCT00770809 Treatment - CALGB: 40601 POST SURGERY HISTOPATHOLOGY REVIEW FORM - 2682513v1.0

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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