ID

6538

Descrição

CALGB 80702 Follow-Up Form Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery NCT01150045 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7ADB9225-BF4C-FA4C-E040-BB89AD4369EB

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=7ADB9225-BF4C-FA4C-E040-BB89AD4369EB

Palavras-chave

Kolorektale Tumoren

Clinical Trial

Follow-Up Studies

27/08/2012 27/08/2012 -
08/01/2015 08/01/2015 - Martin Dugas

Transferido a

8 de janeiro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Follow-Up Form Colorectal Cancer (NCT01150045)

model
Detalhes

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. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the form

1 Formulários

StudyEvent: CALGB 80702 Follow-Up 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. Mark an X in the appropriate box for fields with a choice. Print text in capital letters. Avoid contact with the edges of the boxes. If data are amended, circle amended items and check the "Yes" box. If submitting by mail, retain a copy for your records. If submitting by fax, use an original form for maximum clarity in transmission and fax to 919-416-4990. If submitting electronically, click the Send button when you have completed the form

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Header Module

Item Group

Header Module

Form ID CALGB

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C3262252 (UMLS CUI-1)
C19464 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus ObjectClass-2)

Protocol ID CALGB

Item

CALGB Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Trial subject ID CALGB

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1516238 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25442 (NCI Thesaurus Property-2)

Reporting Period Start Date

Item

Reporting Period Start Date (MM DD YYYY)

date

C15368 (NCI Thesaurus ObjectClass)
C25616 (NCI Thesaurus Property)
C2361257 (UMLS CUI-1)
C25651 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)

Reporting Period End Date

Item

Reporting Period End Date (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C2361259 (UMLS CUI-1)
C25616 (NCI Thesaurus Property)
C15368 (NCI Thesaurus ObjectClass)
C25651 (NCI Thesaurus Property-2)

Data amended

Item

Are data amended

boolean

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

Patient Initials

Item

Patient Initials (Last, First Middle)

text

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

Medical Record Number

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C1301894 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25261 (NCI Thesaurus Property)
C25198 (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)

Participating Group

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C2347449 (UMLS CUI-1)
C25608 (NCI Thesaurus ObjectClass)
C17005 (NCI Thesaurus ObjectClass-2)
C25364 (NCI Thesaurus Property)

Study Number Participating Group

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Trial subject ID Participating Group

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C2347449 (UMLS CUI-2)
C25608 (NCI Thesaurus Property)
C25364 (NCI Thesaurus Property-2)

Person Completing Form

Item

Completed by (Last name, First name)

text

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

Form Completion Date

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C1549507 (UMLS CUI-1)
C25250 (NCI Thesaurus Property)
C25604 (NCI Thesaurus Property-2)
C25164 (NCI Thesaurus ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

SURVIVAL DATA

Item Group

Vital Status

Treatment Status

Item

Treatment type (Mark one with an X.)

text

C15368 (NCI Thesaurus ObjectClass)
C25688 (NCI Thesaurus ValueDomain)
C0749659 (UMLS CUI-1)
C25365 (NCI Thesaurus Property)

CL.2

Code List

Treatment type (Mark one with an X.)

CL Item

On Treatment (On treatment)

CL Item

Follow-up (Follow-up)

C16033 (NCI Thesaurus)
C1522577 (UMLS 2011AA)

Patient Status

Item

Vital Status (Mark one with an X.)

text

C16960 (NCI Thesaurus ObjectClass)
C3846084 (UMLS CUI-1)
C18003 (NCI Thesaurus ValueDomain)
C25688 (NCI Thesaurus ValueDomain-2)
C25717 (NCI Thesaurus Property)

CL.3

Code List

Vital Status (Mark one with an X.)

CL Item

Alive (Alive)

CL Item

Dead (Dead)

Primary Cause of Death

Item

Primary Cause of Death (Mark one with an X.)

text

C25638 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C28554 (NCI Thesaurus Property)
C25251 (NCI Thesaurus ValueDomain-2)

CL.4

Code List

Primary Cause of Death (Mark one with an X.)

CL Item

Due To Protocol Treatment (Due to protocol treatment)

CL Item

Due To This Disease (Due to this disease)

CL Item

Due To Other Cause (Due to other cause)

Cause of Death, specify

Item

Describe cause of death

text

C25685 (NCI Thesaurus ValueDomain)
C0007465 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1521902 (UMLS CUI-2)
C28554 (NCI Thesaurus Property)

Disease Status

Item Group

Disease Status

LaboratoryProcedureCarcinoembryonicAntigenOutcomeValue

Item

CEA Value (ng/mL)

text

C25159 (NCI Thesaurus Property)
C0007082 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property-2)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)

CarcinoembryonicAntigenSpecimenCollectionDate

Item

Date CEA obtained (MM DD YYYY)

text

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25159 (NCI Thesaurus ObjectClass)
C0007082 (UMLS 2011AA ObjectClass)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)

Documented clinical assessment for this cancer

Item

Has the patient had a documented clinical assessment for this cancer?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1522577 (UMLS CUI-1)
C16033 (NCI Thesaurus Property)
C0006826 (UMLS CUI-2)
C9305 (NCI Thesaurus ObjectClass)
C25365 (NCI Thesaurus Property-2)

CancerFollow-UpMostRecentDate

Item

Date of Most Recent Clinical Assessment (MM DD YYYY)

date

C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C16033 (NCI Thesaurus Property)
C1522577 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

DiseasePostSurgicalProcedureDescriptionType

Item

Current disease status (Mark one with an X.)

text

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38008 (NCI Thesaurus Property)
C0687676 (UMLS 2011AA Property)
C15329 (NCI Thesaurus Property-2)
C0543467 (UMLS 2011AA Property-2)
C25365 (NCI Thesaurus Property-3)
C0678257 (UMLS 2011AA Property-3)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.6

Code List

Current disease status (Mark one with an X.)

CL Item

No Evidence Of Disease (No evidence of disease)

CL Item

Relapse/recurrence (Relapse/Recurrence)

CL Item

Died With No Evidence Of Relapse (Died with no evidence of relapse)

Progression/Relapse

Item Group

Sites Of Relapse

DiseaseRecurrentDiseaseCancerProgressionDiagnosisDate

Item

Date of Recurrence (MM DD YYYY)

date

C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C38155 (NCI Thesaurus Property)
C0277556 (UMLS 2011AA Property)
C15220 (NCI Thesaurus Property-2)
C0011900 (UMLS 2011AA Property-2)
C19987 (NCI Thesaurus Property-3)
C0242656 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)

RelapseAnatomicSiteType

Item

Site of relapse/progression (Mark all that apply with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C18265 (NCI Thesaurus ObjectClass)

CL.7

Code List

Site of relapse/progression (Mark all that apply with an X.)

CL Item

Colon (Colon)

C12382 (NCI Thesaurus)
C0009368 (UMLS 2011AA)

CL Item

Bone (Bone)

C12366 (NCI Thesaurus)
C0262950 (UMLS 2011AA)

CL Item

Liver (Liver)

C12392 (NCI Thesaurus)
C0023884 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

RelapseAnatomicSiteSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C13717 (NCI Thesaurus Property)
C1515974 (UMLS 2011AA Property)
C18265 (NCI Thesaurus ObjectClass)

Colonoscopy Information

Item Group

Colonoscopy Information

ColonCarcinomaColonoscopyCurrentPerformedInd-2

Item

Has the patient had a colonoscopy assessment for this cancer since submission of the previous follow-up form?

boolean

C16450 (NCI Thesaurus ObjectClass)
C0009378 (UMLS 2011AA ObjectClass)
C4910 (NCI Thesaurus ObjectClass-2)
C0699790 (UMLS 2011AA ObjectClass-2)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C38000 (NCI Thesaurus Property-2)
C0884358 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

ColonCarcinomaColonoscopyPerformedMostRecentDate

Item

Date of last colonoscopy (MM DD YYYY)

date

C16450 (NCI Thesaurus ObjectClass)
C0009378 (UMLS 2011AA ObjectClass)
C4910 (NCI Thesaurus ObjectClass-2)
C0699790 (UMLS 2011AA ObjectClass-2)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25577 (NCI Thesaurus ValueDomain-2)
C1513491 (UMLS 2011AA ValueDomain-2)

SpecimenSubmittedInd-2

Item

Were any samples sent to pathology

boolean

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)

ColonCarcinomaColonoscopyPerformedStatus

Item

Colonoscopy findings (Mark all that apply with an X.)

text

C16450 (NCI Thesaurus ObjectClass)
C0009378 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C4910 (NCI Thesaurus ObjectClass-2)
C0699790 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)

CL.10

Code List

Colonoscopy findings (Mark all that apply with an X.)

CL Item

Normal (Normal)

C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)

CL Item

Recurrence Of Original Primary Cancer/local Recurrence (Recurrence of original primary cancer/local recurrence)

CL Item

New Primary Colon Cancer (New primary colon cancer)

CL Item

Adenomatous Polyps (Adenomatous polyps)

CL Item

Other Types Of Polyps (Other types of polyps)

Neuropathy

Item Group

Neuropathy

CommonToxicityCriteriaAdverseEventPeripheralSensoryNeuropathyGrade

Item

CTC Adverse Event Peripheral Sensory Neuropathy Grade

text

C49704 (NCI Thesaurus ObjectClass)
C1516728 (UMLS 2011AA ObjectClass)
C0151313 (NCI Metathesaurus Property)
C41331 (NCI Thesaurus ValueDomain)
C0877248 (UMLS 2011AA ValueDomain)
C48309 (NCI Thesaurus ValueDomain-2)
C0441800 (UMLS 2011AA ValueDomain-2)
C25676 (NCI Thesaurus ValueDomain-3)
C0439793 (UMLS 2011AA ValueDomain-3)

CL.11

Code List

CTC Adverse Event Peripheral Sensory Neuropathy Grade

CL Item

Absent Adverse Event (0)

C75533 (NCI Thesaurus)
C2699517 (UMLS 2011AA)

CL Item

Mild Adverse Event (1)

C84263 (NCI Thesaurus)
C1513302 (UMLS 2011AA)

CL Item

Moderate Adverse Event (2)

C84264 (NCI Thesaurus)
C1513374 (UMLS 2011AA)

CL Item

Severe Adverse Event (3)

C84265 (NCI Thesaurus)
C2919019 (UMLS 2011AA)

CL Item

Life Threatening Adverse Event (4)

C84266 (NCI Thesaurus)
C1517874 (UMLS 2011AA)

NON-PROTOCOL TREATMENT

Item Group

Non-protocol Treatment

Non-protocolTherapyCurrentPeriodAdministeredInd-2

Item

Has the patient received any non-protocol cancer therapy during this reporting period?

boolean

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25616 (NCI Thesaurus Property)
C1948053 (UMLS 2011AA Property)
C25471 (NCI Thesaurus Property-2)
C0521116 (UMLS 2011AA Property-2)
C25382 (NCI Thesaurus Property-3)
C1521801 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

Non-ProtocolTherapyOtherAdministeredSpecify

Item

Specify

text

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25382 (NCI Thesaurus Property-2)
C1521801 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

Non-protocolTherapyAdministeredBeginDate

Item

Start Date of Non-protocol Therapy (MM DD YYYY)

date

C15368 (NCI Thesaurus ObjectClass)
C25590 (NCI Thesaurus ObjectClass-2)
C1518384 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25431 (NCI Thesaurus ValueDomain-2)
C0439659 (UMLS 2011AA ValueDomain-2)

NEW PRIMARY DATA

Item Group

New Primary Data

NewCancerDiagnosisInd-3

Item

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

boolean

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)

NewCancerDiagnosisDate

Item

Date of diagnosis (MM DD YYYY)

date

C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)

NewPrimaryCancerSiteType

Item

Site of new primary (Mark one with an X.)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
CL124377 (NCI Metathesaurus ObjectClass)
CL072589 (NCI Metathesaurus ObjectClass-2)

CL.14

Code List

Site of new primary (Mark one with an X.)

CL Item

Breast (Breast)

C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)

CL Item

Lung (Lung)

C12468 (NCI Thesaurus)
C0024109 (UMLS 2011AA)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

CL Item

Prostate (Prostate)

C12410 (NCI Thesaurus)
C0033572 (UMLS 2011AA)

CL Item

Skin (Skin)

C12470 (NCI Thesaurus)
C1123023 (UMLS 2011AA)

NewCancerAnatomicSiteSpecify

Item

Specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C25586 (NCI Thesaurus ObjectClass)
C0205314 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass-2)
C0006826 (UMLS 2011AA ObjectClass-2)

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Follow-Up Form Colorectal Cancer (NCT01150045)

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