Adenocarcinoma of the Gastroesophageal Junction NCT01142388 Eligibility - E2208 Registration Worksheet (step 1) - 3131369v1.0

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

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  1. StudyEvent: E2208 Registration Worksheet (step 1)
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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)
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)
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)
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)
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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