ID

1162

Beskrivning

E2108 Step 2 On-Study Form Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2EE15D-B7A5-69C7-E040-BB89AD431929

Länk

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E2EE15D-B7A5-69C7-E040-BB89AD431929

Nyckelord

C50-C50.9

Uppladdad den

27 augusti 2012

DOI

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Licens

Creative Commons BY-NC 3.0 Legacy

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Breast Cancer NCT01242800 On-Study - E2108 Step 2 On-Study Form - 3130597v1.0

model
Detaljer

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

1 Formulär

StudyEvent: E2108 Step 2 On-Study Form
1. INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Header Module

Item Group

Unnamed1

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

CollectedDataFormName

Item

DCI Name

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus Property)
C0376315 (UMLS 2011AA Property)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25452 (NCI Thesaurus ObjectClass)

RegistrationStepNumber

Item

Registration Step

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C16154 (NCI Thesaurus Property)
C1704379 (UMLS 2011AA Property)
C16154 (NCI Thesaurus ValueDomain)
C1704379 (UMLS 2011AA ValueDomain)

ReportingEvaluationPeriodType

Item

Reporting Period

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus ObjectClass)
C0220825 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25651 (NCI Thesaurus ObjectClass)
C0700287 (UMLS 2011AA ObjectClass)

CL.1

Code List

Reporting Period

CL Item

Baseline Step 2 (Baseline step 2)

PatientECOGIdentifierNumber

Item

ECOG 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)
C25491 (NCI Thesaurus Property)
C1512162 (UMLS 2011AA Property)

Unnamed1

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First)

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)

ProtocolECOGIdentifierNumber

Item

ECOG Protocol Number

text

ProtocolParticipatingIdentifierNumber

Item

Participating Group Protocol Number

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)

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)

PatientECOGIdentifierNumber

Item

ECOG Patient ID

text

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)

Amended Data

Item Group

Unnamed4

DataAmendedText

Item

Please mark an 'X' if data have been amended. (Please circle amended items in red)

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

DataAmendedDate

Item

Date data amended (s M D Y)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)

Patient Characteristics

Item Group

Unnamed3

PerformanceStatusAssessmentEasternCooperativeOncologyGroupScale

Item

ECOG Performance Status (Day 1 of this cycle)

text

C25664 (NCI Thesaurus ValueDomain)
C0349674 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain)
C1512162 (UMLS 2011AA ValueDomain)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)

CL.2

Code List

ECOG Performance Status (Day 1 of this cycle)

CL Item

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

CL Item

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

CL Item

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

CL Item

Capable Of Only Limited Selfcare, Confined To Bed Or Chair More Than 50% Of Waking Hours. (3)

CL Item

Completely Disabled. Cannot Carry On Any Selfcare. Totally Confined To Bed Or Chair. (4)

PatientWeightMeasurement

Item

Weight (kg)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25208 (NCI Thesaurus Property)
C0043100 (UMLS 2011AA Property)

PatientMenopauseStatus

Item

Menopausal status (Definitions of Menopausal Status: Postmenopausal: Defined as at least one of the following: 1 age >55 with no spontaneous menses for at least 12 months, or 2 age </= 55 years with no spontaneous menses within the past 12 months e.g. spontaneous or secondary to hysterectomy AND with an FSH level in the postmenopausal range according to local institutional/laboratory standards or > 34.4 IU/L if the institutional range is not available, or 3 history of bilateral oophorectomy, or 4 receiving gonadotropin releasing hormone to suppress ovarian function during the entire period of planned hormonal therapy. Premenopausal: Defined as spontaneous menses occurring within 3 months prior to pre-randomization, and no prior history of bilateral oophorectomy. Perimenopausal: Not meeting criteria for premenopausal or postmenopausal)

text

C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C3231 (NCI Thesaurus Property)
C0025320 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.3

Code List

CL Item

Postmenopausal (Postmenopausal)

C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)
C15421 (NCI Thesaurus)
C0232970 (UMLS 2011AA)

CL Item

Premenopausal (Premenopausal)

C15491 (NCI Thesaurus)
C0279752 (UMLS 2011AA)

CL Item

Perimenopausal (Perimenopausal)

C15692 (NCI Thesaurus)
C0677925 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

Disease Description

Item Group

Disease Description

BreastCytogeneticsHER2/neuPolyclonalAntibodyTestScore

Item

Her2/neu expression status by immunohistochemistry

text

C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C16487 (NCI Thesaurus ObjectClass)
C0010802 (UMLS 2011AA ObjectClass)
C25294 (NCI Thesaurus Property)
C0022885 (UMLS 2011AA Property)
C17756 (NCI Thesaurus Property)
C0242957 (UMLS 2011AA Property)
C61381 (NCI Thesaurus Property)
C0312586 (UMLS 2011AA Property)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

CL.4

Code List

Her2/neu expression status by immunohistochemistry

CL Item

0 (0)

C0919414 (NCI Metathesaurus)

CL Item

1+ (1+)

CL Item

2+ (2+)

CL Item

3+ (3+)

CL Item

Not Done: C49484 (not done)

C49484 (NCI Thesaurus)
C1272696 (UMLS 2011AA)

FISHAssessmentChromosome17ResultHER2NeuNumber

Item

FISH HER2/neu chromosome 17 Ratio

double

C20989 (NCI Thesaurus ObjectClass)
C0031809 (UMLS 2011AA ObjectClass)
C17563 (NCI Thesaurus ObjectClass)
C0162789 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C13212 (NCI Thesaurus Property)
C0008659 (UMLS 2011AA Property)
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C17756 (NCI Thesaurus ValueDomain)
C0242957 (UMLS 2011AA ValueDomain)

DataUnknownText

Item

Mark an 'X' if not done

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C17998 (NCI Thesaurus Property)
C0439673 (UMLS 2011AA Property)

ERLevelTumorStatus

Item

ER Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)

text

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

CL.5

Code List

ER Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

PgRStatusType

Item

PgR Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)

text

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

CL.6

Code List

PgR Status (Receptor Status as defined by local laboratory; borderline results should be reported as positive)

CL Item

Negative (Negative)

C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)

CL Item

Positive (Positive)

C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)

CL Item

Not Done (NOT DONE)

CL281691 (NCI Metathesaurus)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

OppositeBreastInvolvedInd-3

Item

Opposite Breast (Sites of Involvement At Randomization Record an answer for each site including "Other")

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12971 (NCI Thesaurus ObjectClass)
C0006141 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C25602 (NCI Thesaurus ObjectClass)
C1521805 (UMLS 2011AA ObjectClass)

CL.7

Code List

Opposite Breast (Sites of Involvement At Randomization Record an answer for each site including "Other")

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DistantLymphNodeInvolvedInd-3

Item

Distant Lymph Nodes

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.8

Code List

Distant Lymph Nodes

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

DistantTissueSubcutaneousInvolvedSkinInd-3

Item

Distant Skin/subcutaneous Tissue

text

C25321 (NCI Thesaurus ObjectClass)
C0443203 (UMLS 2011AA ObjectClass)
C12801 (NCI Thesaurus ObjectClass)
C0040300 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)
C13353 (NCI Thesaurus Property)
C0443315 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12470 (NCI Thesaurus ValueDomain)
C1123023 (UMLS 2011AA ValueDomain)

CL.9

Code List

Distant Skin/subcutaneous Tissue

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BoneInvolvedInd-3

Item

Bone

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12366 (NCI Thesaurus ObjectClass)
C0262950 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.10

Code List

Bone

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BoneMarrowInvolvementInd-3

Item

Bone Marrow

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12431 (NCI Thesaurus ObjectClass)
C0005953 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.11

Code List

Bone Marrow

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

LungInvolvedInd-3

Item

Lung

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.12

Code List

Lung

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmLiverMetastaticInvolvementInd-3

Item

Liver

text

C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C12392 (NCI Thesaurus Property)
C0023884 (UMLS 2011AA Property)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.13

Code List

Liver

CL Item

No (NO)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Yes (YES)

PleuraInvolvedInd-3

Item

Pleura

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12469 (NCI Thesaurus ObjectClass)
C0032225 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.14

Code List

Pleura

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

BrainInvolvedInd-3

Item

Brain

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C12439 (NCI Thesaurus ObjectClass)
C0006104 (UMLS 2011AA ObjectClass)
C25547 (NCI Thesaurus Property)

CL.15

Code List

Brain

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

OtherCNSInvolvedSiteInd-3

Item

Other CNS

text

C17649 (NCI Thesaurus ObjectClass)
C0205394 (UMLS 2011AA ObjectClass)
C12438 (NCI Thesaurus ObjectClass)
C0927232 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25547 (NCI Thesaurus Property)
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)

CL.16

Code List

Other CNS

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

MalignantNeoplasmMetastaticInvolvementInd-3

Item

Other

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C14174 (NCI Thesaurus Property)
C0036525 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)

CL.17

Code List

Other

CL Item

No (NO)

CL Item

Yes (YES)

CL Item

Unknown (UNKNOWN)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

TumorExtensionSpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25270 (NCI Thesaurus Property)
C0231448 (UMLS 2011AA Property)

Treatment Plan

Item Group

Treatment Plan

TreatmentPlanAdditionalChemotherapyAdministrationTherapyInd-2

Item

Is further treatment (with Chemotherapy) planned for this patient?

text

C60735 (NCI Thesaurus ObjectClass)
C0599880 (UMLS 2011AA ObjectClass)
C15632 (NCI Thesaurus Property)
C0392920 (UMLS 2011AA Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.18

Code List

Is further treatment (with Chemotherapy) planned for this patient?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

TreatmentPlanAdditionalEndocrineTherapyAdministrationTherapyInd-2

Item

Is further treatment (with Hormone therapy) planned for this patient?

text

C60735 (NCI Thesaurus ObjectClass)
C0599880 (UMLS 2011AA ObjectClass)
C15445 (NCI Thesaurus Property)
C0279025 (UMLS 2011AA Property)
C25406 (NCI Thesaurus Property)
C1524062 (UMLS 2011AA Property)
C25409 (NCI Thesaurus Property)
C1533734 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

CL.19

Code List

Is further treatment (with Hormone therapy) planned for this patient?

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Circulating Tumor Cell (CTC) Enumeration

Item Group

Overall Response Per Recist Criteria - Target, Nontarget And New Lesions

CirculatingTumorCellSpecimenCollectionInd-2

Item

Were circulating tumor cells (CTCs) assessed

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)

CL.20

Code List

Were circulating tumor cells (CTCs) assessed

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

LaboratoryProcedureCirculatingTumorCellResultDate

Item

Date of Enumeration

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C63797 (NCI Thesaurus Property)
C0027625 (UMLS 2011AA Property)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)

CirculatingTumorCellSpecimenCollectionCount

Item

CTC Count (#CTC/mL)

double

C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)

Comments

Item Group

Comments

InvestigatorSignatureText

Item

Investigator Signature

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

InvestigatorSignatureDate

Item

Investigator Signature Date

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25678 (NCI Thesaurus Property)
C1519316 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain)
C17089 (NCI Thesaurus ObjectClass)
C0035173 (UMLS 2011AA ObjectClass)

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Breast Cancer NCT01242800 On-Study - E2108 Step 2 On-Study Form - 3130597v1.0

INSTRUCTIONS: Complete this form and submit original to the ECOG Coordinating Center within one week of registration. Keep a copy for your files

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Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Måttenheter

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning

Datatyp

Alias

Beskrivning