ID

10475

Description

AMC-046 Screen Failure Form Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BEAAEF0-A692-3FA8-E044-0003BA3F9857 NCT00550589

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BEAAEF0-A692-3FA8-E044-0003BA3F9857

Keywords

Versions (3)
  1. 8/26/12 8/26/12 -
  2. 5/22/15 5/22/15 -
  3. 6/3/15 6/3/15 - Julian Varghese
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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AMC-046 Screen Failure Form NCT00550589

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-046 Screen Failure Form
    1. No Instruction available.
Biopsy/Cytology Status
Description

Biopsy/Cytology Status

Anal cytology performed
Description

AnalCytologyPerformedIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C28048
Most Severe Anal Cytology Result (If yes Please record the result from the cytology form)
Description

AnalCytologySpecimenResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C16491
UMLS 2011AA ObjectClass
C0010819
NCI Thesaurus ObjectClass
C19157
UMLS 2011AA ObjectClass
C0370003
NCI Thesaurus ObjectClass
C28048
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
High-resolution anoscopy performed
Description

AnalEndoscopyDiagnosticProcedurePhysicalExaminationInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C16546
UMLS 2011AA ObjectClass
C0014245
NCI Thesaurus ObjectClass
C28048
NCI Thesaurus ObjectClass
C18020
UMLS 2011AA ObjectClass
C0430022
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Perianal biopsy performed
Description

SurroundingAnusBiopsyPerformedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass
C43362
UMLS 2011AA ObjectClass
C0003461
NCI Thesaurus ObjectClass
C52247
UMLS 2011AA ObjectClass
C1282914
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Perianal biopsy result (If yes)
Description

SurroundingAnusBiopsyResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass
C43362
UMLS 2011AA ObjectClass
C0003461
NCI Thesaurus ObjectClass
C52247
UMLS 2011AA ObjectClass
C1282914
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Screen Failure
Description

Screen Failure

Primary reason for screen failure
Description

ScreeningRegistrationClinicalTrialIneligibilityReason

Data type

text

Alias
NCI Thesaurus ObjectClass
C48261
UMLS 2011AA ObjectClass
C1710032
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C15207
NCI Thesaurus Property
C40412
UMLS 2011AA Property
C1512714
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
Other, specify
Description

ScreeningRegistrationClinicalTrialIneligibilitySpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C48261
UMLS 2011AA ObjectClass
C1710032
NCI Thesaurus ObjectClass
C25646
UMLS 2011AA ObjectClass
C1514821
NCI Thesaurus Property
C15207
NCI Thesaurus Property
C40412
UMLS 2011AA Property
C1512714
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Comments
Description

Comments

Comments
Description

ResearchCommentsText

Data type

text

Alias
NCI Thesaurus ValueDomain
C25704
UMLS 2011AA ValueDomain
C1527021
NCI Thesaurus ObjectClass
C15319
NCI Thesaurus Property
C25393
UMLS 2011AA Property
C0282411
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-046 Screen Failure Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Biopsy/Cytology Status
Item
Anal cytology performed
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
CL.1
Code List
Anal cytology performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Most Severe Anal Cytology Result (If yes Please record the result from the cytology form)
text
C16491 (NCI Thesaurus ObjectClass)
C0010819 (UMLS 2011AA ObjectClass)
C19157 (NCI Thesaurus ObjectClass)
C0370003 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.2
Code List
Most Severe Anal Cytology Result (If yes Please record the result from the cytology form)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Ascus (ASCUS)
CL Item
Low Grade Sil (Low grade SIL)
CL Item
Asc-h (ASC-H)
CL Item
High Grade Sil (High grade SIL)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
High-resolution anoscopy performed
text
C16546 (NCI Thesaurus ObjectClass)
C0014245 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus ObjectClass)
C18020 (NCI Thesaurus ObjectClass)
C0430022 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.3
Code List
High-resolution anoscopy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Perianal biopsy performed
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C43362 (NCI Thesaurus ObjectClass)
C0003461 (UMLS 2011AA ObjectClass)
C52247 (NCI Thesaurus ObjectClass)
C1282914 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
CL.4
Code List
Perianal biopsy performed
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Perianal biopsy result (If yes)
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C43362 (NCI Thesaurus ObjectClass)
C0003461 (UMLS 2011AA ObjectClass)
C52247 (NCI Thesaurus ObjectClass)
C1282914 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.5
Code List
Perianal biopsy result (If yes)
CL Item
Normal Squamous Epithelium (Normal squamous epithelium)
CL Item
Squamous Metaplasia (Squamous metaplasia)
C3237 (NCI Thesaurus)
C0025570 (UMLS 2011AA)
CL Item
Condyloma (Condyloma)
CL Item
Flat Condyloma (Flat condyloma)
CL Item
Low-grade Pain (perianal Intraepithelial Neoplasia; Pain 1) (Low-grade PAIN (perianal intraepithelial neoplasia; PAIN 1))
CL Item
High-grade Pain (perianal Intraepithelial Neoplasia; Pain 2 Or 3) (High-grade PAIN (perianal intraepithelial neoplasia; PAIN 2 or 3))
CL Item
Invasive Cancer (Invasive cancer)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item Group
Screen Failure
Item
Primary reason for screen failure
text
C48261 (NCI Thesaurus ObjectClass)
C1710032 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C15207 (NCI Thesaurus Property)
C40412 (NCI Thesaurus Property)
C1512714 (UMLS 2011AA Property)
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
CL.6
Code List
Primary reason for screen failure
CL Item
Not Biopsy Proven Hsil (Not biopsy proven HSIL)
CL Item
Laboratory Parameters Not Met (Laboratory parameters not met)
CL Item
Participant Pregnant (Participant Pregnant)
CL Item
Plans To Start Antiretroviral Therapy Prior To Week 12 (Plans to start antiretroviral therapy prior to week 12)
CL Item
Cd4 Cell Count (CD4 cell count)
CL Item
Change In Antiretroviral Therapy Within 12 Weeks Of Enrollment (Change in antiretroviral therapy within 12 weeks of enrollment)
CL Item
Serious Illness Within 45 Days Prior To Entry (Serious illness within 45 days prior to entry)
CL Item
Participant Withdrew Consent (Participant withdrew consent)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
ScreeningRegistrationClinicalTrialIneligibilitySpecify
Item
Other, specify
text
C48261 (NCI Thesaurus ObjectClass)
C1710032 (UMLS 2011AA ObjectClass)
C25646 (NCI Thesaurus ObjectClass)
C1514821 (UMLS 2011AA ObjectClass)
C15207 (NCI Thesaurus Property)
C40412 (NCI Thesaurus Property)
C1512714 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item Group
Comments
ResearchCommentsText
Item
Comments
text
C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C15319 (NCI Thesaurus ObjectClass)
C25393 (NCI Thesaurus Property)
C0282411 (UMLS 2011AA Property)
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