AMC-046 Screen Failure Form NCT00550589

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

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  1. StudyEvent: AMC-046 Screen Failure Form
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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)
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)
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)
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)
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)
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)
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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