ID

10919

Description

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

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=804A6A4D-69FB-2D51-E040-BB89AD4340B3

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 6/12/15 6/12/15 -
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June 12, 2015

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Creative Commons BY-NC 3.0 Legacy
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SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM NCT00382018

English

No Instruction available.

1 forms  
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM
    1. No Instruction available.
Header
Description

Header

SWOG Patient ID
Description

Trial subject ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
SWOG Study No.
Description

Protocol ID SWOG

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C3274381
NCI Thesaurus ObjectClass
C25320
UMLS CUI-2
C1519429
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C25699
Registration Step
Description

Registration Number

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C1514821
NCI Thesaurus ObjectClass
C25646
UMLS CUI-2
C0237753
NCI Thesaurus Property
C16154
NCI Thesaurus ValueDomain-2
C16154
Patient Initials (L, F M)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
CTC submission timepoint
Description

CirculatingTumorCellSpecimenTimepointSubmissionType

Data type

text

Alias
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C68568
UMLS 2011AA Property
C2348792
NCI Thesaurus Property-2
C25694
UMLS 2011AA Property-2
C1515022
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Institution/Affiliate
Description

Institution Name

Data type

text

Alias
NCI Thesaurus ObjectClass
C25454
UMLS CUI-1
C1301943
NCI Thesaurus ObjectClass-2
C21541
NCI Thesaurus Property
C25364
NCI Thesaurus ValueDomain
C25191
NCI Thesaurus ValueDomain-2
C21541
Physician (Participating Group:)
Description

Investigator Name

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2826892
NCI Thesaurus Property
C25364
NCI Thesaurus ObjectClass
C17089
NCI Thesaurus ObjectClass-2
C25644
Group Name
Description

GroupName

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS 2011AA ValueDomain
C1547383
NCI Thesaurus ObjectClass
C17005
UMLS 2011AA ObjectClass
C1257890
NCI Thesaurus Property
C25364
UMLS 2011AA Property
C0600091
Participating Group Study No.
Description

Study Number Participating Group

Data type

text

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

Trial subject ID Participating Group

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C2347449
NCI Thesaurus Property
C25608
NCI Thesaurus Property-2
C25364
Blood sample
Description

Blood sample

Was the blood sample drawn and submitted to Veridex for this timepoint
Description

CirculatingTumorCellSpecimenTimepointSubmissionInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C68568
UMLS 2011AA Property
C2348792
NCI Thesaurus Property-2
C25694
UMLS 2011AA Property-2
C1515022
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Date of blood sample collection (IF yes,)
Description

CirculatingTumorCellSpecimenCollectionDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
Was this a repeat blood sample collection for this submission timepoint
Description

CirculatingTumorCellSpecimenRepeatCollectionInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C25453
UMLS 2011AA Property
C1516698
NCI Thesaurus Property-2
C47886
UMLS 2011AA Property-2
C0205341
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Will the patient remain on study for future CTC blood draws
Description

CirculatingTumorCellSpecimenOnStudyFutureCollectionInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C63797
UMLS 2011AA ObjectClass
C0027625
NCI Thesaurus ObjectClass-2
C19157
UMLS 2011AA ObjectClass-2
C0370003
NCI Thesaurus Property
C67527
UMLS 2011AA Property
C0016884
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C73469
UMLS 2011AA Property-3
C2349977
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Off-protocol treatment
Description

Off-protocol treatment

Off treatment reason
Description

PersonCirculatingTumorCellCollectionOffTreatmentReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C63797
UMLS 2011AA Property-3
C0027625
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

PersonCirculatingTumorCellCollectionOffTreatmentSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C63797
UMLS 2011AA Property-3
C0027625
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Off treatment date (Date of completion, progression, death, or decision to discontinue CTC blood draws)
Description

PersonCirculatingTumorCellCollectionOffTreatmentDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C25601
UMLS 2011AA Property
C1518544
NCI Thesaurus Property-2
C25453
UMLS 2011AA Property-2
C1516698
NCI Thesaurus Property-3
C63797
UMLS 2011AA Property-3
C0027625
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Comments
Description

Comments

Comments
Description

Research Comments

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS CUI-1
C0947611
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: SOUTHWEST ONCOLOGY GROUP S0500 CTC SUBMISSION FORM
    1. No Instruction available.
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)
CL.1
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)
CL.5
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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