ID

1094

Descrizione

CALGB 40601 FOLLOW-UP SOLID TUMOR 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=3CB30144-0173-5B57-E044-0003BA3F9857

collegamento

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3CB30144-0173-5B57-E044-0003BA3F9857

Keywords

D005500

Breast Neoplasms

Caricato su

27 agosto 2012

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT00770809 Response - CALGB 40601 FOLLOW-UP SOLID TUMOR EVALUATION FORM - 2690188v1.0

model
Dettagli

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 moduli

StudyEvent: CALGB 40601 FOLLOW-UP SOLID TUMOR EVALUATION 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

genere

Description | Question | Decode (Coded Value)

Tipo di dati

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)

TreatmentReportingPeriodBeginDate

Item

Reporting Period Start Date

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus Property)
C0700287 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain)
C0439659 (UMLS 2011AA ValueDomain)

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)

TARGET LESION(S) FOLLOW-UP EVALUATION

Item Group

Reporting Period

LesionTargetSite

Item

Target Lesion Site

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property)
C1521840 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

CL.2

Code List

Target Lesion Site

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Chest Wall (Chest wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Gastrointestinal Tract (Gastrointestinal tract)

C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)

CL Item

Gynecologic Other (Gynecologic other)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Distant Nodes (Nodes distant)

CL Item

Nodes Local (Nodes local)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Primary Tumor (Primary tumor)

CL Item

Skin / Subcutaneous Tissue Involvement (Skin subcutaneous)

DiseaseInvolvementSiteOtherSpecify

Item

Other specify

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C17649 (NCI Thesaurus ValueDomain)
C0205394 (UMLS 2011AA ValueDomain)

LesionLongestDiameterMeasurement

Item

Longest Diameter of Lesion(s) (s)

double

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property)
C1522425 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain)
C1301886 (UMLS 2011AA ValueDomain)

LesionAssessmentDate

Item

Date of evaluation (MM DD YYYY)

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)

LongestLesionSumDiameterMeasurement

Item

Sum of Longest Diameters of All Target Lesions

double

C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property)
C1515051 (UMLS 2011AA Property)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA 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.15

Code List

Method of Evaluation (**)

CL Item

Clinical (Clinical Examination)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Chest X-ray (Chest X-ray)

CL Item

Ct Scan (CT Scan)

CL Item

Spiral Ct Scan (Spiral CT Scan)

CL Item

Mri (MRI)

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Bone Scan (Bone Scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TargetLesionResponseStatus

Item

Response Status at This Assessment, Target Lesion (s)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass)
C1521840 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.4

Code List

Response Status at This Assessment, Target Lesion (s)

CL Item

Complete Response (Complete Response)

CL Item

Partial Response (Partial Response)

CL Item

Stable Disease (Stable Disease)

C18213 (NCI Thesaurus)
C0677946 (UMLS 2011AA)

CL Item

Progressive Disease (Progressive Disease)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)

EvaluationMethodSpecify

Item

If Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C16847 (NCI Thesaurus Property)
C0449851 (UMLS 2011AA Property)

NON-TARGET LESION(S) FOLLOW-UP EVALUATION

Item Group

Non-target Lesion(s) Follow-up Evaluation

LesionNontargetSite

Item

Nontarget Lesion Site

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus Property)
C1518389 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

CL.6

Code List

Nontarget Lesion Site

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Chest Wall (Chest wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Gastrointestinal Tract (Gastrointestinal tract)

C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)

CL Item

Gynecologic Other (Gynecologic other)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Distant Nodes (Nodes distant)

CL Item

Nodes Local (Nodes local)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Primary Tumor (Primary tumor)

CL Item

Skin / Subcutaneous Tissue Involvement (Skin subcutaneous)

DiseaseInvolvementSiteOtherSpecify

Item

Other specify

text

LesionAssessmentDate

Item

Date of evaluation (MM DD YYYY)

date

Follow-upLesionResponseStatus

Item

F/U Response Status (Use response status codes below.)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C16033 (NCI Thesaurus ObjectClass)
C1522577 (UMLS 2011AA ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.8

Code List

F/U Response Status (Use response status codes below.)

CL Item

Complete Response (Complete Response)

CL Item

Incomplete Response/sd (Incomplete Response/SD)

CL Item

Progressive Disease (Progressive Disease)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)

AssessmentMethodType

Item

Method of Evaluation (**)

text

CL.15

Code List

Method of Evaluation (**)

CL Item

Clinical (Clinical Examination)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Chest X-ray (Chest X-ray)

CL Item

Ct Scan (CT Scan)

CL Item

Spiral Ct Scan (Spiral CT Scan)

CL Item

Mri (MRI)

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Bone Scan (Bone Scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

Non-TargetLesionResponseStatus

Item

Response Status at This Assessment, Non-Target Lesion (s)

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass)
C1518389 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.9

Code List

Response Status at This Assessment, Non-Target Lesion (s)

CL Item

Complete Response (Complete Response)

CL Item

Incomplete Response/sd (Incomplete Response/SD)

CL Item

Progressive Disease (Progressive Disease)

C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)

CL Item

Insufficient Evaluation To Determine Response Status (Insufficient evaluation to determine response status)

EvaluationMethodSpecify

Item

If Other, specify

text

NontargetLesionPresentInd-2

Item

Nontarget Lesion

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass)
C1518389 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)

CL.17

Code List

Nontarget Lesion

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NEW LESION(S) AT FOLLOW-UP EVALUATION

Item Group

New Lesion(s) At Follow-up Evaluation

NewLesionAppearanceInd-2

Item

Was the appearance of any new lesions documented

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)

CL.10

Code List

Was the appearance of any new lesions documented

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LesionPriorLocationDiagnosisInd-2

Item

Were any of the new lesion(s) in a previously reported anatomic site

text

C71163 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.11

Code List

Were any of the new lesion(s) in a previously reported anatomic site

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LesionNewLocationDiagnosisInd-2

Item

Was the lesion in a new anatomic site

text

C71163 (NCI Thesaurus ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.12

Code List

Was the lesion in a new anatomic site

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LesionPriorLocationDiagnosisAnatomicSite

Item

Lesion in previously reported site

text

C71163 (NCI Thesaurus ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25629 (NCI Thesaurus Property)
C0332152 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

CL.13

Code List

Lesion in previously reported site

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Chest Wall (Chest wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Gastrointestinal Tract (Gastrointestinal tract)

C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)

CL Item

Gynecologic Other (Gynecologic other)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Distant Nodes (Nodes distant)

CL Item

Nodes Local (Nodes local)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Primary Tumor (Primary tumor)

CL Item

Skin / Subcutaneous Tissue Involvement (Skin subcutaneous)

LesionNewSite

Item

New Lesion Site

text

C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C37901 (NCI Thesaurus ValueDomain)
C0205145 (UMLS 2011AA ValueDomain)

CL.14

Code List

New Lesion Site

CL Item

Ascites (Ascites)

C2885 (NCI Thesaurus)
C0003962 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Bone Marrow (Bone marrow)

C12431 (NCI Thesaurus)
C0005953 (UMLS 2011AA)

CL Item

Brain (Brain)

CL Item

Chest Wall (Chest wall)

CL035093 (NCI Metathesaurus)
C62484 (NCI Thesaurus)
C0205076 (UMLS 2011AA)

CL Item

Gastrointestinal Tract (Gastrointestinal tract)

C34082 (NCI Thesaurus)
C0017189 (UMLS 2011AA)

CL Item

Gynecologic Other (Gynecologic other)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Distant Nodes (Nodes distant)

CL Item

Nodes Local (Nodes local)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Ovary (Ovary)

C12404 (NCI Thesaurus)
C0029939 (UMLS 2011AA)

CL Item

Peritoneum (Peritoneum)

C12770 (NCI Thesaurus)
C0031153 (UMLS 2011AA)

CL Item

Pleura (Pleura)

C12469 (NCI Thesaurus)
C0032225 (UMLS 2011AA)

CL Item

Primary Tumor (Primary tumor)

CL Item

Skin / Subcutaneous Tissue Involvement (Skin subcutaneous)

DiseaseInvolvementSiteOtherSpecify

Item

Other specify

text

LesionAssessmentDate

Item

Date of evaluation (MM DD YYYY)

date

AssessmentMethodType

Item

Method of Evaluation (**)

text

CL.15

Code List

Method of Evaluation (**)

CL Item

Clinical (Clinical Examination)

C25398 (NCI Thesaurus)
C0205210 (UMLS 2011AA)

CL Item

Chest X-ray (Chest X-ray)

CL Item

Ct Scan (CT Scan)

CL Item

Spiral Ct Scan (Spiral CT Scan)

CL Item

Mri (MRI)

CL Item

Ultrasound (Ultrasound)

C64384 (NCI Thesaurus)
C1456803 (UMLS 2011AA)

CL Item

Bone Scan (Bone Scan)

C17646 (NCI Thesaurus)
C0203668 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

EvaluationMethodSpecify

Item

If Other, specify

text

TargetLesionPresentInd-2

Item

Target Lesion

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass)
C1521840 (UMLS 2011AA ObjectClass)

CL.16

Code List

Target Lesion

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

NontargetLesionPresentInd-2

Item

Nontarget Lesion

text

CL.17

Code List

Nontarget Lesion

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Footer module

Item Group

Overall Response

ResponsiblePersonName

Item

Completed by (print or type 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 Response - CALGB 40601 FOLLOW-UP SOLID TUMOR EVALUATION FORM - 2690188v1.0

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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