ID

10584

Description

AMC-052 Eligibility Checklist Segment B 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=3BAEF387-E2CE-2E35-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=3BAEF387-E2CE-2E35-E044-0003BA3F9857

Keywords

  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 Eligibility Checklist Segment B NCT00513526

No Instruction available.

  1. StudyEvent: AMC-052 Eligibility Checklist Segment B
    1. No Instruction available.
Inclusion Criteria
Description

Inclusion Criteria

Inclusion Criteria
Description

AIDSMalignancyConsortiumPatientInclusionClinicalTrialEligibilityCriteria052Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25532
UMLS 2011AA Property-2
C1512693
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Exclusion Criteria
Description

Exclusion Criteria

Exclusion Criteria
Description

AIDSMalignancyConsortiumPatientExclusionClinicalTrialEligibilityCriteria052Type

Data type

text

Alias
NCI Thesaurus ObjectClass
C16960
UMLS 2011AA ObjectClass
C0030705
NCI Thesaurus ObjectClass-2
C19707
UMLS 2011AA ObjectClass-2
C1515830
NCI Thesaurus Property
C16112
UMLS 2011AA Property
C1516637
NCI Thesaurus Property-2
C25370
UMLS 2011AA Property-2
C0680251
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
Karnofsky Performance Status
Description

KarnofskyPerformanceStatusScore

Data type

text

Alias
NCI Thesaurus Property
C25367
NCI Thesaurus ObjectClass
C20641
UMLS 2011AA ObjectClass
C1518965
NCI Thesaurus ValueDomain
C25338
UMLS 2011AA ValueDomain
C0449820

Similar models

No Instruction available.

  1. StudyEvent: AMC-052 Eligibility Checklist Segment B
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Item
Inclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25532 (NCI Thesaurus Property-2)
C1512693 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Inclusion Criteria
CL Item
Anal Hpv Dna Pcr Result: Type 16; Positive, Negative Type 18; Positive, Negative (Anal HPV DNA PCR result: Type 16; positive, negative Type 18; positive, negative)
CL Item
Did The Participant Have A Normal Anal Cytological Results, Or Ascus/lsil Result, Within 45 Days Prior To Entry (Did the participant have a normal anal cytological results, or ASCUS/LSIL result, within 45 days prior to entry)
CL Item
Is The Participant Receiving Antiretroviral Therapy (Is the participant receiving antiretroviral therapy)
CL Item
Karnofsky Performance Status (must Be >=70 And Assessed Within 45 Or Fewer Days Prior To Entry) (Karnofsky performance status (must be >=70 and assessed within 45 or fewer days prior to entry))
CL Item
Were The Following Hematologic Parameters Met And Performed Within 45 Days Prior To Study Entry: Absolute Neutrophil Count (>750 Cells/mm^3); Hemoglobin (>=9.0 G/dl); Platelet Count (>=100,000/ Mm^3) (Were the following hematologic parameters met and performed within 45 days prior to study entry: Absolute neutrophil count (>750 cells/mm^3); Hemoglobin (>=9.0 g/dL); Platelet count (>=100,000/ mm^3))
CL Item
Were The Following Laboratory Parameters Met And Performed Within 45 Days Prior To Study Entry: Creatinine (<=3 X Uln); Ast (<=3 X Uln); Alt (<=3 X Uln); Bilirubin (total Or Direct) (<=2.5 X Uln) (Were the following laboratory parameters met and performed within 45 days prior to study entry: Creatinine (<=3 x ULN); AST (<=3 x ULN); ALT (<=3 x ULN); Bilirubin (total or direct) (<=2.5 x ULN))
CL Item
Is The Participant's Screening Cd4+ Cell Count >200 Cells/mm^3 (Is the participant's screening CD4+ cell count >200 cells/mm^3)
CL Item
Is The Participant's Screening Plasma Hiv-1 Rna Result (i.e. Viral Load) Below The Limit Of Detection (with The Lower Limit Of Detection 200 Copies Or Less) Or Detectable But < 200 Copies/ml (Is the participant's screening plasma HIV-1 RNA result (i.e. viral load) below the limit of detection (with the lower limit of detection 200 copies or less) or detectable but < 200 copies/ml)
CL Item
Has The Participant Received Antiretroviral Therapy Continuously (i.e. No Interruptions Of Antiretroviral Therapy Lasting Longer Then 7 Days) For At Least 6 Months Prior To Entry (Has the participant received antiretroviral therapy continuously (i.e. no interruptions of antiretroviral therapy lasting longer then 7 days) for at least 6 months prior to entry)
CL Item
Has The Participant's Antiretroviral Therapy Remained Unchanged In The 30 Days Prior To Entry (Has the participant's antiretroviral therapy remained unchanged in the 30 days prior to entry)
CL Item
Is The Participant's Screening Cd4+ Cell Count >=350 Cells/mm^3 (within 90 Days Prior To Entry) (Is the participant's screening CD4+ cell count >=350 cells/mm^3 (within 90 days prior to entry))
CL Item
Is The Participant Planning To Remain Off Antiretroviral Therapy Within 28 Weeks After Entry (Is the participant planning to remain off antiretroviral therapy within 28 weeks after entry)
Item Group
Exclusion Criteria
Item
Exclusion Criteria
text
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C19707 (NCI Thesaurus ObjectClass-2)
C1515830 (UMLS 2011AA ObjectClass-2)
C16112 (NCI Thesaurus Property)
C1516637 (UMLS 2011AA Property)
C25370 (NCI Thesaurus Property-2)
C0680251 (UMLS 2011AA Property-2)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
Code List
Exclusion Criteria
CL Item
Did The Participant Have Serious Illness Requiring Systemic Treatment And/or Hospitalization Within 45 Days Prior To Entry (Did the participant have serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry)
CL Item
Does The Participant Have A History Of Anal Cytological Result With Hsil, Atypical Squamous Cells Suggestive Of Hsil, Or Suggestive Of Carcinoma (Does the participant have a history of anal cytological result with HSIL, atypical squamous cells suggestive of HSIL, or suggestive of carcinoma)
CL Item
Does The Participant Have A History Of Anal Or Perianal Carcinoma (Does the participant have a history of anal or perianal carcinoma)
CL Item
Does The Participant Have A History Of High Grade Ain (i.e. Ain 2 Or 3) Or High Grade Perianal Intraepithelial Neoplasia (Does the participant have a history of high grade AIN (i.e. AIN 2 or 3) or high grade perianal intraepithelial neoplasia)
CL Item
Does The Participant Have Active Drug Or Alcohol Use Or Dependence That, In The Opinion Of The Site Investigator, Would Interfere With Adherence To Study Requirements (Does the participant have active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements)
CL Item
Has The Participant Received Any Systemic Antineoplastic Or Immunomodulatory Treatment, Systemic Corticosteroids, Investigational Vaccines, Interleukins, Interferons, Growth Factors, Or Ivig, <=45 Days Prior To Entry (Has the participant received any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG, <=45 days prior to entry)
CL Item
Is The Participant Receiving Anticoagulation Therapy Other Than Acetylsalicylic Acid At The Time Of Entry (Is the participant receiving anticoagulation therapy other than acetylsalicylic acid at the time of entry)
KarnofskyPerformanceStatusScore
Item
Karnofsky Performance Status
text
C25367 (NCI Thesaurus Property)
C20641 (NCI Thesaurus ObjectClass)
C1518965 (UMLS 2011AA ObjectClass)
C25338 (NCI Thesaurus ValueDomain)
C0449820 (UMLS 2011AA ValueDomain)

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