ID

8966

Description

E7208 Registration Worksheet (step 1) Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=917D26EA-3F70-45A5-E040-BB89AD431DBE

Lien

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=917D26EA-3F70-45A5-E040-BB89AD431DBE

Mots-clés

  1. 27/08/2012 27/08/2012 -
  2. 09/01/2015 09/01/2015 - Martin Dugas
Téléchargé le

9 janvier 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT01079780 Eligibility - E7208 Registration Worksheet (step 1) - 3144427v1.0

No Instruction available.

  1. StudyEvent: E7208 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Description

Eligibility

Has the eligibility checklist been completed
Description

EligibilityDeterminationChecklistCompleteEligibilityInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus Property
C25250
UMLS 2011AA Property
C0205197
NCI Thesaurus ObjectClass
C25171
UMLS 2011AA ObjectClass
C0013893
NCI Thesaurus Property-2
C49073
UMLS 2011AA Property-2
C1707357
In the opinion of the investigator, is the patient eligible?
Description

Eligibility for trial

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38148
UMLS CUI-1
C1302261
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25171
Has written informed consent been obtained
Description

Consent signed

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS CUI-1
C0742766
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25678
NCI Thesaurus Property-2
C25460
Date Informed Consent Signed
Description

InformedConsentFormSignedDate

Type de données

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ValueDomain-2
C25367
NCI Thesaurus ObjectClass
C16468
UMLS 2011AA ObjectClass
C0009797
NCI Thesaurus Property
C25679
Has HIPAA authorization been obtained
Description

HealthInsurancePortabilityandAccountabilityActAuthorizationIndicator

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C62504
UMLS 2011AA ObjectClass
C0600593
NCI Thesaurus Property
C41192
UMLS 2011AA Property
C1524004
HIPAA Authorization Date
Description

PatientSignedDischargeMedicalRecordDate

Type de données

date

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C25679
NCI Metathesaurus Property
C0012621
NCI Thesaurus Property-2
C45258
UMLS 2011AA Property
C0025102
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
ECOG Performance Status
Description

ECOG Performance Status

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25664
UMLS CUI-1
C1520224
NCI Thesaurus Property
C25367
NCI Thesaurus ValueDomain-2
C25491
NCI Thesaurus ObjectClass
C20641
Discontinuation of oxaliplatin first line therapy before disease progression
Description

OxaliplatinFirst-LineTherapyDiscontinuedInd-2

Type de données

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C1181
UMLS 2011AA ObjectClass
C0069717
NCI Thesaurus Property
C25484
UMLS 2011AA Property
C1444662
NCI Thesaurus ObjectClass-2
C45792
UMLS 2011AA ObjectClass-2
C1708063
Time frame of progression
Description

MalignantNeoplasmCancerProgressionOccurrenceType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus Property
C19987
UMLS 2011AA Property
C0242656
NCI Thesaurus Property-2
C25275
UMLS 2011AA Property-2
C2745955
Patient's simplified disease code
Description

DiseaseInvolvementType

Type de données

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C25548
UMLS 2011AA Property
C1314939
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat cancer? This may also include research on inherited traits (genes passed on in families).
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-3
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-4
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)? This may also include research on inherited traits (genes passed on in families).
Description

SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C25699
UMLS 2011AA ObjectClass-2
C1519429
NCI Thesaurus Property
C12801
UMLS 2011AA Property
C0040300
NCI Thesaurus Property-2
C19157
UMLS 2011AA Property-2
C0370003
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-3
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Someone from my hospital or the Eastern Cooperative Oncology Group may contact me in the future to ask me to take part in more research.
Description

PatientAdditionalResearchConsentInd-2

Type de données

boolean

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15319
NCI Thesaurus Property-2
C25406
UMLS 2011AA Property
C1524062
NCI Thesaurus Property-3
C25460
UMLS 2011AA Property-2
C1511481
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698

Similar models

No Instruction available.

  1. StudyEvent: E7208 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Eligibility
EligibilityDeterminationChecklistCompleteEligibilityInd-2
Item
Has the eligibility checklist been completed
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25171 (NCI Thesaurus ObjectClass)
C0013893 (UMLS 2011AA ObjectClass)
C49073 (NCI Thesaurus Property-2)
C1707357 (UMLS 2011AA Property-2)
Eligibility for trial
Item
In the opinion of the investigator, is the patient eligible?
boolean
C38148 (NCI Thesaurus ValueDomain)
C1302261 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25171 (NCI Thesaurus Property)
Consent signed
Item
Has written informed consent been obtained
boolean
C38147 (NCI Thesaurus ValueDomain)
C0742766 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25678 (NCI Thesaurus Property)
C25460 (NCI Thesaurus Property-2)
InformedConsentFormSignedDate
Item
Date Informed Consent Signed
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain-2)
C16468 (NCI Thesaurus ObjectClass)
C0009797 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
Item
Has HIPAA authorization been obtained
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C62504 (NCI Thesaurus ObjectClass)
C0600593 (UMLS 2011AA ObjectClass)
C41192 (NCI Thesaurus Property)
C1524004 (UMLS 2011AA Property)
Code List
Has HIPAA authorization been obtained
CL Item
No: C49487 (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes: C49488 (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
CL Item
Exempt - Non-usa Participant (Exempt - non-USA participant)
PatientSignedDischargeMedicalRecordDate
Item
HIPAA Authorization Date
date
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25679 (NCI Thesaurus Property)
C0012621 (NCI Metathesaurus Property)
C45258 (NCI Thesaurus Property-2)
C0025102 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item
ECOG Performance Status
text
C25664 (NCI Thesaurus ValueDomain)
C1520224 (UMLS CUI-1)
C25367 (NCI Thesaurus Property)
C25491 (NCI Thesaurus ValueDomain-2)
C20641 (NCI Thesaurus ObjectClass)
Code List
ECOG Performance Status
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)
CL Item
Dead (5)
OxaliplatinFirst-LineTherapyDiscontinuedInd-2
Item
Discontinuation of oxaliplatin first line therapy before disease progression
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C1181 (NCI Thesaurus ObjectClass)
C0069717 (UMLS 2011AA ObjectClass)
C25484 (NCI Thesaurus Property)
C1444662 (UMLS 2011AA Property)
C45792 (NCI Thesaurus ObjectClass-2)
C1708063 (UMLS 2011AA ObjectClass-2)
Item
Time frame of progression
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C19987 (NCI Thesaurus Property)
C0242656 (UMLS 2011AA Property)
C25275 (NCI Thesaurus Property-2)
C2745955 (UMLS 2011AA Property-2)
Code List
Time frame of progression
CL Item
Within 6 Months Of Last Treatment (Within 6 months of last treatment)
CL Item
Greater Than 6 Months Since Last Treatment (Greater than 6 months since last treatment)
Item
Patient's simplified disease code
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C25548 (NCI Thesaurus Property)
C1314939 (UMLS 2011AA Property)
Code List
Patient's simplified disease code
CL Item
Adenocarcinoma Colon (Adenocarcinoma of the colon)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C12382 (NCI Thesaurus-3)
C0009368 (UMLS 2011AA-4)
CL Item
Colorectal Carcinoma Not Otherwise Specified (Colorectal cancer, NOS)
C19594 (NCI Thesaurus)
C1518425 (UMLS 2011AA)
C2955 (NCI Thesaurus-3)
C0009402 (UMLS 2011AA-4)
CL Item
Adenocarcinoma Rectum (Adenocarcinoma of the rectum)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
C12390 (NCI Thesaurus-3)
C0034896 (UMLS 2011AA-4)
PersonSpecimenMalignantNeoplasmResearchConsentInd-2
Item
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat cancer? This may also include research on inherited traits (genes passed on in families).
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C9305 (NCI Thesaurus Property-2)
C0006826 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-3)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
SouthwestOncologyGroupPatientTissueSpecimenConsentInd-2
Item
May your coded samples and related coded information be kept for use in research to learn about, prevent, find or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)? This may also include research on inherited traits (genes passed on in families).
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25699 (NCI Thesaurus ObjectClass-2)
C1519429 (UMLS 2011AA ObjectClass-2)
C12801 (NCI Thesaurus Property)
C0040300 (UMLS 2011AA Property)
C19157 (NCI Thesaurus Property-2)
C0370003 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
PatientAdditionalResearchConsentInd-2
Item
Someone from my hospital or the Eastern Cooperative Oncology Group may contact me in the future to ask me to take part in more research.
boolean
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15319 (NCI Thesaurus Property)
C25406 (NCI Thesaurus Property-2)
C1524062 (UMLS 2011AA Property)
C25460 (NCI Thesaurus Property-3)
C1511481 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)

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