ID

1142

Beschrijving

CALGB: 40601 PRE-NEOADJUVANT CHEMOTHERAPY SURGICAL EVALUATION 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=3A963C4E-69F2-4844-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A963C4E-69F2-4844-E044-0003BA3F9857

Trefwoorden

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27 augustus 2012

DOI

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Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00770809 Pre-Study - CALGB: 40601 PRE-NEOADJUVANT CHEMOTHERAPY SURGICAL EVALUATION FORM - 2683338v1.0

model
Details

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

1 Formulieren

StudyEvent: CALGB: 40601 PRE-NEOADJUVANT CHEMOTHERAPY SURGICAL EVALUATION FORM
1. INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

Name

Type

Description | Question | Decode (Coded Value)

Datatype

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)

AssessmentPerformedDate

Item

Date of evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ObjectClass)
C25367 (NCI Thesaurus ValueDomain)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Amended Data

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

Amended Data

CL Item

Yes (yes)

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

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First Middle)

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)

Breast Conserving Therapy

Item Group

Breast Conserving Therapy

ClinicalBreastExaminationNormalEvaluationInd-2

Item

Was the patient's clinical breast exam normal?

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C14165 (NCI Thesaurus Property)
C0205307 (UMLS 2011AA Property)
C70552 (NCI Thesaurus ObjectClass)
C2347781 (UMLS 2011AA ObjectClass)

CL.2

Code List

Was the patient's clinical breast exam normal?

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)

ClinicalBreastExaminationAbnormalEvaluationText

Item

Describe abnormality (If no,)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25401 (NCI Thesaurus Property)
C0205161 (UMLS 2011AA Property)
C70552 (NCI Thesaurus ObjectClass)
C2347781 (UMLS 2011AA ObjectClass)

BreastConservationTreatmentPriorNeoadjuvantTherapyQualificationInd-2

Item

Is the patient currently(before receiving neoadjuvant chemotherapy) a candidate for breast conserving treatment

text

C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C43608 (NCI Thesaurus Property)
C1709790 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.3

Code List

Is the patient currently(before receiving neoadjuvant chemotherapy) a candidate for breast conserving treatment

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastConservationTreatmentPriorNeoadjuvantTherapyNotQualificationReason

Item

Reason not a candidate (If no,)

text

C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
CL052458 (NCI Metathesaurus Property)
C43608 (NCI Thesaurus Property)
C1709790 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)

CL.4

Code List

Reason not a candidate (If no,)

CL Item

Absolute Contraindication To Radiation Therapy (Absolute contraindication to radiation therapy)

CL Item

Diffuse Suspicious Microcalcifications (Diffuse suspicious microcalcifications)

CL Item

Multicentric Breast Cancer (Multicentric breast cancer)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Probable Poor Cosmetic Outcome (Probable poor cosmetic outcome)

CL Item

Breast Cancer Pt4 Tnm Finding (T4)

C48985 (NCI Thesaurus)
C1707033 (UMLS 2011AA)

CL Item

Tumor Is Too Large In Relation To Native Breast Size (Tumor is too large in relation to native breast size)

BreastConservationTreatmentPriorNeoadjuvantTherapyNotQualificationSpecify

Item

Other, specify

text

C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
CL052458 (NCI Metathesaurus Property)
C43608 (NCI Thesaurus Property)
C1709790 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

BreastConservationTreatmentRadiationTherapyMedicalContraindicationReason

Item

Absolute contraindication to radiation therapy

text

C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C50646 (NCI Thesaurus Property)
C1301624 (UMLS 2011AA Property)

CL.5

Code List

Absolute contraindication to radiation therapy

CL Item

Connective Tissue Disorder (Connective Tissue Disorder)

C26729 (NCI Thesaurus)
C0009782 (UMLS 2011AA)

CL Item

Patient Access To Prescribed Radiation Therapy (Patient access to prescribed radiation therapy)

CL Item

Patient Compliance With Prescribed Radiation Therapy (Patient compliance with prescribed radiation therapy)

CL Item

Prior Radiation Therapy (Prior radiation therapy)

C15477 (NCI Thesaurus)
C0279134 (UMLS 2011AA)

BreastConservationTreatmentRadiationTherapyConnectiveTissueDisorderMedicalContraindicationSpecify

Item

Connective tissue disorder, specify

text

C15313 (NCI Thesaurus ObjectClass)
C1522449 (UMLS 2011AA ObjectClass)
C15280 (NCI Thesaurus ObjectClass)
C0917927 (UMLS 2011AA ObjectClass)
C26729 (NCI Thesaurus Property)
C0009782 (UMLS 2011AA Property)
C50646 (NCI Thesaurus Property)
C1301624 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Axillary Node

Item Group

Axillary Node

AxillaryLymphNodePriorNeoadjuvantTherapyEvaluationInd-2

Item

Was the patient's pre-neoadjuvent chemotherapy treatment axillary nodal status evaluated?

text

C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.6

Code List

Was the patient's pre-neoadjuvent chemotherapy treatment axillary nodal status evaluated?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

BreastTumorClinicalNStage

Item

Clinical N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.8

Code List

Clinical N Stage

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Movable Ipsilateral Axillary Lymph Node(s) (N1)

CL Item

Metastasis To Ipsilateral Axillary Lymph Node(s) Fixed Or Matted, Or In Clinically Apparent* Ipsilateral Internal Mammary Nodes In The Absence Of Clinically Evident Lymph Node Metastasis (N2)

UltrasoundImagingPositiveFindingResultText

Item

If positive, specify why ultrasound criteria made it positive

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C17230 (NCI Thesaurus ObjectClass)
C0041618 (UMLS 2011AA ObjectClass)

LesionAssessmentDate

Item

Date of Evaluation

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

AssessmentMethodType

Item

Method of Evaluation

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

CL.10

Code List

Method of Evaluation

CL Item

Axillary Dissection (Axillary dissection)

CL Item

Excisional Biopsy Or Lumpectomy (Excisional biopsy or lumpectomy)

CL Item

Fine Needle Aspiration Biopsy (Fine needle aspiration biopsy)

CL Item

Mri Scan (MRI scan)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pet Scan (PET scan)

CL Item

Sentinel Node Biopsy (Sentinel node biopsy)

AssessmentMethodType

Item

Method of Evaluation

text

CL.10

Code List

Method of Evaluation

CL Item

Axillary Dissection (Axillary dissection)

CL Item

Excisional Biopsy Or Lumpectomy (Excisional biopsy or lumpectomy)

CL Item

Fine Needle Aspiration Biopsy (Fine needle aspiration biopsy)

CL Item

Mri Scan (MRI scan)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Pet Scan (PET scan)

CL Item

Sentinel Node Biopsy (Sentinel node biopsy)

AssessmentMethodSpecify

Item

Other Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

AxillaryLymphNodePostNeoadjuvantTherapyEvaluationResult

Item

Results

text

C12904 (NCI Thesaurus ObjectClass)
C0729594 (UMLS 2011AA ObjectClass)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15665 (NCI Thesaurus Property)
C0600558 (UMLS 2011AA Property)
C20200 (NCI Thesaurus ValueDomain)
C1274040 (UMLS 2011AA ValueDomain)

CL.11

Code List

Results

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Applicable (N/A)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

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)

AxillaryLymphNodePostNeoadjuvantTherapyEvaluationResult

Item

Results

text

CL.11

Code List

Results

CL Item

Equivocal (Equivocal)

C86071 (NCI Thesaurus)
C0332241 (UMLS 2011AA)

CL Item

Not Applicable (N/A)

C48660 (NCI Thesaurus)
C1272460 (UMLS 2011AA)

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)

SentinelNodeBiopsyDate

Item

Sentinel Node Biopsy Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)
C15189 (NCI Thesaurus Property)
C0005558 (UMLS 2011AA Property)
C12947 (NCI Thesaurus ObjectClass)
C1522495 (UMLS 2011AA ObjectClass)

SentinelLymphNodeBiopsyBlueDyeUseInd-2

Item

Was blue dye used

text

C15667 (NCI Thesaurus ObjectClass)
C0796693 (UMLS 2011AA ObjectClass)
C461 (NCI Thesaurus Property)
C0013343 (UMLS 2011AA Property)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C48333 (NCI Thesaurus Property)
C1260957 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.12

Code List

Was blue dye used

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SentinelLymphNodeBiopsyTechnetium99mDextranUseInd-2

Item

Was technetium used

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C15667 (NCI Thesaurus ObjectClass)
C0796693 (UMLS 2011AA ObjectClass)
C25340 (NCI Thesaurus Property)
C0457083 (UMLS 2011AA Property)
C1243 (NCI Thesaurus Property)
C0076028 (UMLS 2011AA Property)

CL.13

Code List

Was technetium used

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LymphNodeDissectionDate

Item

Date of dissection

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C15227 (NCI Thesaurus Property)
C0012737 (UMLS 2011AA Property)

Comments

Item Group

Required Laboratory Values

ResearchCommentsText

Item

Comments

text

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

Footer Module

Item Group

Footer Module

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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Item Commentaren voor :

Breast Cancer NCT00770809 Pre-Study - CALGB: 40601 PRE-NEOADJUVANT CHEMOTHERAPY SURGICAL EVALUATION FORM - 2683338v1.0

INSTRUCTIONS: Complete all information on this form. Submit within one week of registration along with the On-Study Form.

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