SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM NCT00382018

SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM NCT00382018 Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=804A6A4D-69FB-2D51-E040-BB89AD4340B3

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  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM
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Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Trial subject ID SWOG
Item
SWOG Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Protocol ID SWOG
Item
SWOG Study No.
text
C25337 (NCI Thesaurus ValueDomain)
C3274381 (UMLS CUI-1)
C25320 (NCI Thesaurus ObjectClass)
C1519429 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C25699 (NCI Thesaurus Property-2)
Registration Number
Item
Registration Step
text
C25337 (NCI Thesaurus ValueDomain)
C1514821 (UMLS CUI-1)
C25646 (NCI Thesaurus ObjectClass)
C0237753 (UMLS CUI-2)
C16154 (NCI Thesaurus Property)
C16154 (NCI Thesaurus ValueDomain-2)
Patient Initials
Item
Patient Initials (L, F M)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Item
CTC submission timepoint
text
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C25694 (NCI Thesaurus Property-2)
C1515022 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
CTC submission timepoint
CL Item
Day 169 (Day 169)
CL Item
Day 22 (Day 22)
CL Item
Day 253 (Day 253)
CL Item
Day 50/57 (Day 50/57)
CL Item
Day 85 (Day 85)
CL Item
Pretreatment (Pretreatment)
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)
Investigator Name
Item
Physician (Participating Group:)
text
C25191 (NCI Thesaurus ValueDomain)
C2826892 (UMLS CUI-1)
C25364 (NCI Thesaurus Property)
C17089 (NCI Thesaurus ObjectClass)
C25644 (NCI Thesaurus ObjectClass-2)
GroupName
Item
Group Name
text
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA 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 (Instructions: All dates are MONTH, DAY, YEAR. Explain any blank fields or blank dates in the Comments section. Place an X in appropriate boxes. Circle AMENDED items in red and write AMENDED across the top of the form.)
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)
Item Group
Blood sample
CirculatingTumorCellSpecimenTimepointSubmissionInd-2
Item
Was the blood sample drawn and submitted to Veridex for this timepoint
boolean
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C68568 (NCI Thesaurus Property)
C2348792 (UMLS 2011AA Property)
C25694 (NCI Thesaurus Property-2)
C1515022 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CirculatingTumorCellSpecimenCollectionDate
Item
Date of blood sample collection (IF yes,)
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
CirculatingTumorCellSpecimenRepeatCollectionInd-2
Item
Was this a repeat blood sample collection for this submission timepoint
boolean
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C25453 (NCI Thesaurus Property)
C1516698 (UMLS 2011AA Property)
C47886 (NCI Thesaurus Property-2)
C0205341 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CirculatingTumorCellSpecimenOnStudyFutureCollectionInd-2
Item
Will the patient remain on study for future CTC blood draws
boolean
C63797 (NCI Thesaurus ObjectClass)
C0027625 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass-2)
C0370003 (UMLS 2011AA ObjectClass-2)
C67527 (NCI Thesaurus Property)
C0016884 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C73469 (NCI Thesaurus Property-3)
C2349977 (UMLS 2011AA Property-3)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item Group
Off-protocol treatment
Item
Off treatment reason
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C63797 (NCI Thesaurus Property-3)
C0027625 (UMLS 2011AA Property-3)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
Code List
Off treatment reason
CL Item
Day 253 Blood Draw Completed Per Protocol Criteria (Day 253 blood draw completed per protocol criteria)
CL Item
Death (Death)
C28554 (NCI Thesaurus)
C0011065 (UMLS 2011AA)
CL Item
Other (Other)
CL Item
Patient Withdrew Consent For All Future Blood Draws (Patient withdrew consent for all future blood draws)
CL Item
Progression Or Relapse (Progression or relapse)
PersonCirculatingTumorCellCollectionOffTreatmentSpecify
Item
Other, specify
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C63797 (NCI Thesaurus Property-3)
C0027625 (UMLS 2011AA Property-3)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
PersonCirculatingTumorCellCollectionOffTreatmentDate
Item
Off treatment date (Date of completion, progression, death, or decision to discontinue CTC blood draws)
date
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C25601 (NCI Thesaurus Property)
C1518544 (UMLS 2011AA Property)
C25453 (NCI Thesaurus Property-2)
C1516698 (UMLS 2011AA Property-2)
C63797 (NCI Thesaurus Property-3)
C0027625 (UMLS 2011AA Property-3)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
Item Group
Comments
Research Comments
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C0947611 (UMLS CUI-1)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)

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