ID

9070

Description

E2208 Registration Worksheet (step 1) Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E830FA8-C594-2081-E040-BB89AD43554F

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8E830FA8-C594-2081-E040-BB89AD43554F

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Adenocarcinoma of the Gastroesophageal Junction NCT01142388 Eligibility - E2208 Registration Worksheet (step 1) - 3131369v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: E2208 Registration Worksheet (step 1)
    1. No Instruction available.
Eligibility
Description

Eligibility

Has the eligibility checklist been completed
Description

EligibilityDeterminationChecklistCompleteEligibilityInd-2

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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

Data type

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
Tumor Location
Description

ClinicalStudyMalignantNeoplasmAnatomicSite

Data type

text

Alias
NCI Thesaurus ValueDomain
C13717
UMLS 2011AA ValueDomain
C1515974
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus ObjectClass
C9305
UMLS 2011AA ObjectClass
C0006826
NCI Thesaurus ObjectClass-2
C15206
UMLS 2011AA ObjectClass-2
C0008972
Histologic Type
Description

HeadandNeckTumorHistologicCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C3262
UMLS 2011AA ObjectClass
C0027651
NCI Thesaurus ObjectClass-2
C12418
UMLS 2011AA ObjectClass-2
C0460004
NCI Thesaurus Property
C25526
UMLS 2011AA Property
C0205462
NCI Thesaurus Property-2
C25161
UMLS 2011AA Property-2
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
NCI Thesaurus ValueDomain-2
C25526
UMLS 2011AA ValueDomain-2
C0205462
Patient's simplified disease code
Description

PersonMalignantNeoplasmClinicalTrialEligibilityCriteriaType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C9305
UMLS 2011AA Property
C0006826
NCI Thesaurus Property-2
C16112
UMLS 2011AA Property-2
C1516637
I agree to participate in the laboratory research studies that are being done as part of this clinical trial.
Description

PersonLaboratoryProcedureCurrentClinicalTrialConsentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25471
UMLS 2011AA Property
C0521116
NCI Thesaurus Property-2
C15207
NCI Thesaurus Property-3
C25294
UMLS 2011AA Property-2
C0022885
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 cancer? This may also include research on inherited traits (genes passed on in families).
Description

PersonSpecimenMalignantNeoplasmResearchConsentInd-2

Data type

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

Data type

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

Data type

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
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No Instruction available.

1 forms
  1. StudyEvent: E2208 Registration Worksheet (step 1)
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
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)
CL.4
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
Tumor Location
text
C13717 (NCI Thesaurus ValueDomain)
C1515974 (UMLS 2011AA ValueDomain)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C9305 (NCI Thesaurus ObjectClass)
C0006826 (UMLS 2011AA ObjectClass)
C15206 (NCI Thesaurus ObjectClass-2)
C0008972 (UMLS 2011AA ObjectClass-2)
CL.5
Code List
Tumor Location
CL Item
Gastroesophageal Junction (Gastroesophageal Junction)
C32668 (NCI Thesaurus)
C0014871 (UMLS 2011AA)
CL Item
Esophagus (Esophagus)
C12389 (NCI Thesaurus)
C0014876 (UMLS 2011AA)
Item
Histologic Type
text
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12418 (NCI Thesaurus ObjectClass-2)
C0460004 (UMLS 2011AA ObjectClass-2)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property-2)
C0008902 (UMLS 2011AA Property-2)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain-2)
C0205462 (UMLS 2011AA ValueDomain-2)
CL.6
Code List
Histologic Type
CL Item
Squamous Cell Carcinoma (Squamous Cell Carcinoma)
C2929 (NCI Thesaurus)
C0007137 (UMLS 2011AA)
CL Item
Adenocarcinoma (Adenocarcinoma)
C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)
Item
Patient's simplified disease code
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C9305 (NCI Thesaurus Property)
C0006826 (UMLS 2011AA Property)
C16112 (NCI Thesaurus Property-2)
C1516637 (UMLS 2011AA Property-2)
CL.7
Code List
Patient's simplified disease code
CL Item
Adenocarcinoma Of The Esophagus (Adenocarcinoma of the esophagus)
CL Item
Esophageal Cancer, Nos (Esophageal cancer, NOS)
CL Item
Squamous Cell Carcinoma Of The Esophagus (Squamous cell carcinoma of the esophagus)
CL Item
Adenocarcinoma Of The Gastroesophageal Junction (Adenocarcinoma of the gastroesophageal junction)
PersonLaboratoryProcedureCurrentClinicalTrialConsentInd-2
Item
I agree to participate in the laboratory research studies that are being done as part of this clinical trial.
boolean
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25471 (NCI Thesaurus Property)
C0521116 (UMLS 2011AA Property)
C15207 (NCI Thesaurus Property-2)
C25294 (NCI Thesaurus Property-3)
C0022885 (UMLS 2011AA Property-2)
C25460 (NCI Thesaurus Property-4)
C1511481 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
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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