ID

1774

Description

AMC-052 HPV On-Study Form Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3950D614-2D59-3AAB-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3950D614-2D59-3AAB-E044-0003BA3F9857

Keywords

Versions (4)
  1. 9/19/12 9/19/12 -
  2. 8/11/14 8/11/14 - Martin Dugas
  3. 6/2/15 6/2/15 -
  4. 6/3/15 6/3/15 -
Uploaded on

September 19, 2012

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Infection NCT00513526 On-Study - AMC-052 HPV On-Study Form - 2676566v1.0

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-052 HPV On-Study Form
    1. No Instruction available.
Unnamed1
Description

Unnamed1

Date of HIV+ diagnosis
Description

HumanImmunodeficiencyVirusDiagnosisDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C14219
UMLS 2011AA ObjectClass
C0019682
NCI Thesaurus Property
C15220
UMLS 2011AA Property
C0011900
CDC HIV Risk Group
Description

PatientHumanImmunodeficiencyVirusRiskCategory

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C14219
UMLS 2011AA Property
C0019682
NCI Thesaurus Property
C17102
UMLS 2011AA Property
C0035647
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus ValueDomain
C25372
UMLS 2011AA ValueDomain
C0683312
Other, specify
Description

PatientHumanImmunodeficiencyVirusRiskCategorySpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C14219
UMLS 2011AA Property
C0019682
NCI Thesaurus Property
C17102
UMLS 2011AA Property
C0035647
NCI Thesaurus Property
C25161
UMLS 2011AA Property
C0008902
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
Prior Systemic Chemotherapy
Description

PriorChemotherapyAdministeredInd-3

Data type

text

Alias
NCI Thesaurus ValueDomain
C38148
UMLS 2011AA ValueDomain
C1512699
NCI Thesaurus ObjectClass
C15632
UMLS 2011AA ObjectClass
C0392920
NCI Thesaurus ObjectClass
C25629
UMLS 2011AA ObjectClass
C0332152
NCI Thesaurus Property
C25382
UMLS 2011AA Property
C1521801
Has the patient received radiation therapy?
Description

PatientRadiationTherapyReceivedInd-2

Data type

text

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus Property
C15313
UMLS 2011AA Property
C1522449
NCI Thesaurus Property
C25639
UMLS 2011AA Property
C1514756
Unnamed2
Description

Unnamed2

History of anal, perianal, or genital condyloma (If yes check all that apply)
Description

HumanPapillomavirusDiseaseGenitalAnalCondylomaPersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C14226
UMLS 2011AA ObjectClass
C0021344
NCI Thesaurus Property
C13348
UMLS 2011AA Property
C0559522
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C4054
UMLS 2011AA Property
C0281779
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
History of penile or genital condyloma
Description

HumanPapillomavirusDiseaseGenitalPenisCondylomaPersonalMedicalHistoryStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C14226
UMLS 2011AA ObjectClass
C0021344
NCI Thesaurus Property
C13348
UMLS 2011AA Property
C0559522
NCI Thesaurus Property
C12409
UMLS 2011AA Property
C0030851
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C2960
UMLS 2011AA Property
C0009663
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
History of perianal condyloma
Description

HumanPapillomavirusDiseaseAnalCondylomaSurroundingPersonalMedicalHistoryStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C14226
UMLS 2011AA ObjectClass
C0021344
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C52247
UMLS 2011AA Property
C1282914
NCI Thesaurus Property
C4054
UMLS 2011AA Property
C0281779
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
History of intraanal condlyoma
Description

HumanPapillomavirusDiseaseAnalCondylomaInternalPersonalMedicalHistoryStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus ObjectClass
C14226
UMLS 2011AA ObjectClass
C0021344
NCI Thesaurus Property
C25234
UMLS 2011AA Property
C0205102
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C4054
UMLS 2011AA Property
C0281779
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Unnamed3
Description

Unnamed3

Anal cytology performed (prior to screening to AMC052)
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
Anal cytology result (if yes)
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
Anal or perianal biopsy performed (prior to screening to AMC052)
Description

AnalSurroundingAnusBiopsyPerformedIndicator

Data type

text

Alias
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus ObjectClass
C43362
UMLS 2011AA ObjectClass
C0003461
NCI Thesaurus ObjectClass
C28048
NCI Thesaurus ObjectClass
C52247
UMLS 2011AA ObjectClass
C1282914
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
Most severe anal biopsy result
Description

AnalBiopsyResultType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus ObjectClass
C28048
Unnamed4
Description

Unnamed4

Smoked at least 100 cigarettes (5 packs) during lifetime
Description

SmokingHistoryIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C17934
UMLS 2011AA ObjectClass
C0453996
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
Lowest CD4+ count ever reported
Description

LaboratoryProcedureCD4+LowestResultCount

Data type

double

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C12537
UMLS 2011AA Property
C0039215
NCI Thesaurus Property
C43517
UMLS 2011AA Property
C1708760
NCI Thesaurus ValueDomain
C25463
UMLS 2011AA ValueDomain
C0750480
Document type
Description

ProtocolDocumentSubmittedType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C42651
UMLS 2011AA ObjectClass
C0442711
NCI Thesaurus ObjectClass
C19498
UMLS 2011AA ObjectClass
C1547673
NCI Thesaurus Property
C25695
UMLS 2011AA Property
C1515023
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-052 HPV On-Study Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unnamed1
HumanImmunodeficiencyVirusDiagnosisDate
Item
Date of HIV+ diagnosis
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C14219 (NCI Thesaurus ObjectClass)
C0019682 (UMLS 2011AA ObjectClass)
C15220 (NCI Thesaurus Property)
C0011900 (UMLS 2011AA Property)
Item
CDC HIV Risk Group
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C17102 (NCI Thesaurus Property)
C0035647 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
CL.1
Code List
CDC HIV Risk Group
CL Item
Hemophilia (Hemophiliac)
C3093 (NCI Thesaurus)
C0684275 (UMLS 2011AA)
CL Item
Heterosexual Contact (Heterosexual contact)
CL Item
Homosexual Or Bisexual Contact (Homosexual or bisexual contact)
CL Item
Iv Drug User (IV drug user)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Transfusion Recipient (Transfusion recipient)
PatientHumanImmunodeficiencyVirusRiskCategorySpecify
Item
Other, specify
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C14219 (NCI Thesaurus Property)
C0019682 (UMLS 2011AA Property)
C17102 (NCI Thesaurus Property)
C0035647 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
Item
Prior Systemic Chemotherapy
text
C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C15632 (NCI Thesaurus ObjectClass)
C0392920 (UMLS 2011AA ObjectClass)
C25629 (NCI Thesaurus ObjectClass)
C0332152 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
CL.2
Code List
Prior Systemic Chemotherapy
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Has the patient received radiation therapy?
text
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C15313 (NCI Thesaurus Property)
C1522449 (UMLS 2011AA Property)
C25639 (NCI Thesaurus Property)
C1514756 (UMLS 2011AA Property)
CL.3
Code List
Has the patient received radiation therapy?
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item Group
Unnamed2
Item
History of anal, perianal, or genital condyloma (If yes check all that apply)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14226 (NCI Thesaurus ObjectClass)
C0021344 (UMLS 2011AA ObjectClass)
C13348 (NCI Thesaurus Property)
C0559522 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C4054 (NCI Thesaurus Property)
C0281779 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.4
Code List
History of anal, perianal, or genital condyloma (If yes check all that apply)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
History of penile or genital condyloma
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14226 (NCI Thesaurus ObjectClass)
C0021344 (UMLS 2011AA ObjectClass)
C13348 (NCI Thesaurus Property)
C0559522 (UMLS 2011AA Property)
C12409 (NCI Thesaurus Property)
C0030851 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C2960 (NCI Thesaurus Property)
C0009663 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.5
Code List
History of penile or genital condyloma
CL Item
Active Genital Condyloma (Active genital condyloma)
CL Item
Active Penile Condyloma (Active penile condyloma)
CL Item
No History (No history)
CL Item
Yes, Resolved With History Of Treatment (Yes, resolved with history of treatment)
CL Item
Yes, Resolved Without Treatment (Yes, resolved without treatment)
Item
History of perianal condyloma
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14226 (NCI Thesaurus ObjectClass)
C0021344 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C52247 (NCI Thesaurus Property)
C1282914 (UMLS 2011AA Property)
C4054 (NCI Thesaurus Property)
C0281779 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.6
Code List
History of perianal condyloma
CL Item
Active Perianal Condyloma (Active perianal condyloma)
CL Item
No History (No history)
CL Item
Yes, Resolved With History Of Treatment (Yes, resolved with history of treatment)
CL Item
Yes, Resolved Without Treatment (Yes, resolved without treatment)
Item
History of intraanal condlyoma
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C14226 (NCI Thesaurus ObjectClass)
C0021344 (UMLS 2011AA ObjectClass)
C25234 (NCI Thesaurus Property)
C0205102 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C4054 (NCI Thesaurus Property)
C0281779 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.7
Code List
History of intraanal condlyoma
CL Item
Active Intraanal Condyloma (Active intraanal condyloma)
CL Item
No History (No history)
CL Item
Yes, Resolved With History Of Treatment (Yes, resolved with history of treatment)
CL Item
Yes, Resolved Without Treatment (Yes, resolved without treatment)
Item Group
Unnamed3
Item
Anal cytology performed (prior to screening to AMC052)
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.8
Code List
Anal cytology performed (prior to screening to AMC052)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Participant Does Not Recall (Participant does not recall)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Anal cytology result (if yes)
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.9
Code List
Anal cytology result (if yes)
CL Item
Asc-h (ASC-H)
CL Item
Ascus (ASCUS)
CL Item
High Grade Sil (High grade SIL)
CL Item
Low Grade Sil (Low grade SIL)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
No Information Available (Results not available)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item
Anal or perianal biopsy performed (prior to screening to AMC052)
text
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C43362 (NCI Thesaurus ObjectClass)
C0003461 (UMLS 2011AA ObjectClass)
C28048 (NCI Thesaurus 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.10
Code List
Anal or perianal biopsy performed (prior to screening to AMC052)
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Participant Does Not Recall (Participant does not recall)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
Most severe anal biopsy result
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
CL.11
Code List
Most severe anal biopsy result
CL Item
Condyloma (Condyloma)
CL Item
High-grade Ain (High-grade AIN)
CL Item
Invasive Cancer (Invasive cancer)
CL Item
Low-grade Ain (Low-grade AIN)
CL Item
Normal (Normal)
C14165 (NCI Thesaurus)
C0205307 (UMLS 2011AA)
CL Item
Squamous Metaplasia (Squamous metaplasia)
C3237 (NCI Thesaurus)
C0025570 (UMLS 2011AA)
CL Item
Unknown (Unknown)
C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)
Item Group
Unnamed4
Item
Smoked at least 100 cigarettes (5 packs) during lifetime
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C17934 (NCI Thesaurus ObjectClass)
C0453996 (UMLS 2011AA ObjectClass)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
CL.12
Code List
Smoked at least 100 cigarettes (5 packs) during lifetime
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
LaboratoryProcedureCD4+LowestResultCount
Item
Lowest CD4+ count ever reported
double
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12537 (NCI Thesaurus Property)
C0039215 (UMLS 2011AA Property)
C43517 (NCI Thesaurus Property)
C1708760 (UMLS 2011AA Property)
C25463 (NCI Thesaurus ValueDomain)
C0750480 (UMLS 2011AA ValueDomain)
Item
Document type
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C42651 (NCI Thesaurus ObjectClass)
C0442711 (UMLS 2011AA ObjectClass)
C19498 (NCI Thesaurus ObjectClass)
C1547673 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus Property)
C1515023 (UMLS 2011AA Property)
CL.13
Code List
Document type
CL Item
Lab Report (Lab Report)
CL Item
Physician/provider Report Or Clinical Note (Physician/provider report or clinical note)
CL Item
Subject Recall (Subject recall)
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