ID

10589

Description

AMC-052 Screen Failure Form NCT00513526 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=3A53B09A-E5AB-7491-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3A53B09A-E5AB-7491-E044-0003BA3F9857

Keywords

Versions (3)
  1. 9/19/12 9/19/12 -
  2. 5/28/15 5/28/15 -
  3. 6/3/15 6/3/15 -
Uploaded on

June 3, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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AMC-052 Screen Failure Form NCT00513526

English

No Instruction available.

1 forms  
  1. StudyEvent: AMC-052 Screen Failure Form
    1. No Instruction available.
Patient infection medical history
Description

Patient infection medical history

HIV risk factor present
Description

PatientHumanImmunodeficiencyVirusRiskCategoryInd-2

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
C38147
UMLS 2011AA ValueDomain
C1512698
History of intravenous drug use
Description

PersonIntravenousDrugAbusePersonalMedicalHistoryInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25190
UMLS 2011AA ObjectClass
C0027361
NCI Thesaurus Property
C13346
UMLS 2011AA Property
C0348016
NCI Thesaurus Property
C18772
UMLS 2011AA Property
C0262926
NCI Thesaurus Property
C16522
UMLS 2011AA Property
C0013146
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
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
Anal cytology result
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
Anal biopsy performed
Description

AnalBiopsyPerformedIndicator

Data type

text

Alias
NCI Thesaurus ValueDomain
C25180
UMLS 2011AA ValueDomain
C1522602
NCI Thesaurus ObjectClass
C15189
UMLS 2011AA ObjectClass
C0005558
NCI Thesaurus Property
C38000
UMLS 2011AA Property
C0884358
NCI Thesaurus ObjectClass
C28048
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
Anal HPV DNA PCR obtained
Description

LaboratoryProcedureAnalHumanPapillomavirusPolymeraseChainReactionResultInd-2

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17003
UMLS 2011AA Property
C0032520
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C14226
UMLS 2011AA Property
C0021344
NCI Thesaurus Property
C28048
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
HPV Type 16 Results
Description

LaboratoryProcedureAnalHumanPapillomavirus-16PolymeraseChainReactionResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17003
UMLS 2011AA Property
C0032520
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C28048
NCI Thesaurus Property
C14338
UMLS 2011AA Property
C0999806
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
HPV Type 18 Results
Description

LaboratoryProcedureAnalHumanPapillomavirus-18PolymeraseChainReactionResultType

Data type

text

Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C17003
UMLS 2011AA Property
C0032520
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property
C28048
NCI Thesaurus Property
C14377
UMLS 2011AA Property
C0999807
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
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Similar models

No Instruction available.

1 forms
  1. StudyEvent: AMC-052 Screen Failure Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient infection medical history
Item
HIV risk factor present
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)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.1
Code List
HIV risk factor present
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
History of intravenous drug use
text
C25190 (NCI Thesaurus ObjectClass)
C0027361 (UMLS 2011AA ObjectClass)
C13346 (NCI Thesaurus Property)
C0348016 (UMLS 2011AA Property)
C18772 (NCI Thesaurus Property)
C0262926 (UMLS 2011AA Property)
C16522 (NCI Thesaurus Property)
C0013146 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.2
Code List
History of intravenous drug use
CL Item
No (No)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (Yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
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.3
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
Anal cytology result
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.4
Code List
Anal cytology result
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
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.5
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
Anal biopsy performed
text
C25180 (NCI Thesaurus ValueDomain)
C1522602 (UMLS 2011AA ValueDomain)
C15189 (NCI Thesaurus ObjectClass)
C0005558 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C28048 (NCI Thesaurus ObjectClass)
CL.6
Code List
Anal biopsy 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 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.7
Code List
Most severe anal biopsy result
CL Item
Colonic Epithelium (Colonic epithelium)
CL Item
Condyloma (Condyloma)
CL Item
Flat Condyloma (Flat 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 Squamous Epithelium (Normal squamous epithelium)
CL Item
Squamous Metaplasia (Squamous metaplasia)
C3237 (NCI Thesaurus)
C0025570 (UMLS 2011AA)
CL Item
Unevaluable (Unevaluable)
C62222 (NCI Thesaurus)
C1883425 (UMLS 2011AA)
Item
Anal HPV DNA PCR obtained
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C14226 (NCI Thesaurus Property)
C0021344 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
CL.8
Code List
Anal HPV DNA PCR obtained
CL Item
No (no)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)
CL Item
Yes (yes)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
Item
HPV Type 16 Results
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C14338 (NCI Thesaurus Property)
C0999806 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.9
Code List
HPV Type 16 Results
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
CL Item
Results Not Available (Results not available)
Item
HPV Type 18 Results
text
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C17003 (NCI Thesaurus Property)
C0032520 (UMLS 2011AA Property)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C28048 (NCI Thesaurus Property)
C14377 (NCI Thesaurus Property)
C0999807 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
CL.10
Code List
HPV Type 18 Results
CL Item
Negative (Negative)
C25247 (NCI Thesaurus)
C0205160 (UMLS 2011AA)
CL Item
Positive (Positive)
C25246 (NCI Thesaurus)
C1446409 (UMLS 2011AA)
CL Item
Not Done (Not done)
CL281691 (NCI Metathesaurus)
CL Item
Results Not Available (Results not available)
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.11
Code List
Primary reason for screen failure
CL Item
Antiretroviral Therapy Not Continuous For At Least 6 Months Prior To Entry (Antiretroviral therapy not continuous for at least 6 months prior to entry)
CL Item
Change In Antiretroviral Therapy (Change in antiretroviral therapy)
CL Item
Cd4 Cell Count (CD4 cell count)
CL Item
Hiv-1 Rna (HIV-1 RNA)
CL Item
Plans To Start Antiretroviral Therapy Prior To Week 28 (Plans to start antiretroviral therapy prior to Week 28)
CL Item
Hematologic Parameters Not Met (Hematologic parameters not met)
CL Item
Laboratory Parameters Not Met (Laboratory parameters not met)
CL Item
Current Or History Of Anal Or Perianal Carcinoma (Current or history of anal or perianal carcinoma)
CL Item
Use Of Any Systemic Antineoplastic Or Immunomodulatory Treatment, Systemic Corticosteroids, Investigational Vaccines, Interleukins, Interferons, Growth Factors, Or Ivig Within 45 Days Prior To Study Entry (Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry)
CL Item
Active Drug Or Alcohol Use Or Dependence That, In The Opinion Of The Site Investigator, Would Interfere With Adherence To Study Requirements (Active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements)
CL Item
Serious Illness Requiring Systemic Treatment And/or Hospitalization Within 45 Days Prior To Entry (Serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry)
CL Item
Participant Is Currently Receiving Anticoagulation Therapy Other Than Acetylsalicylic Acid (Participant is currently receiving anticoagulation therapy other than acetylsalicylic acid)
CL Item
Participant Withdrew Consent (Participant withdrew consent)
CL Item
The Maximum Number Of Participants With Hpv Type 16 Are Already Enrolled (The maximum number of participants with HPV type 16 are already enrolled)
CL Item
The Maximum Number Of Participants With Hpv Type 18 Are Already Enrolled (The maximum number of participants with HPV type 18 are already enrolled)
CL Item
The Maximum Number Of Participants On Antiretroviral Therapy Are Already Enrolled (The maximum number of participants on antiretroviral therapy are already enrolled)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
CL Item
Positive For Both Hpv Type 16 And Hpv Type 18 (Positive for both HPV type 16 and HPV type 18)
CL Item
Anal Cytology With Hsil, Asc-h, Or Suggestive Of Carcinoma (Anal cytology with HSIL, ASC-H, or suggestive of carcinoma)
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)
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