Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
NCT ID: NCT01946139
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2013-12-04
2018-10-31
Brief Summary
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Detailed Description
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I. To determine the sensitivity and specificity of HPV testing using different methods of detection, including HPV Hybrid Capture 2 (HC2), HPV messenger ribonucleic acid (mRNA) assays (APTIMA) and OncoHealth HPV E6/E7 oncoprotein assay and whether they improve the screening performance of routine anal cytology for the detection of anal high-grade squamous intraepithelial lesions (HSIL) when measured against the gold standard, biopsy-proven HSIL.
II. To determine the prevalence and risk factors for prevalent HSIL in HIV-infected women.
III. To determine incidence and risk factors associated with anal HSIL and HPV over 2 years among HIV infected women undergoing semi-annual anal evaluations.
EXPLORATORY OBJECTIVES:
I. To evaluate the acceptability of anal cancer screening among HIV-infected women.
II. To collect data on quality of life and health care costs (including non-direct health care costs and time costs) for an economic evaluation of the cost-effectiveness of anal cancer screening strategies in HIV-positive women.
OUTLINE:
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 12 and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening (HSIL detection)
Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
comparison of screening methods
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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comparison of screening methods
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status \> 70%
* Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry
* Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry
Exclusion Criteria
* History of anal HSIL cytology or histology
* Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal
* For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study
* Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol
* Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS)
* Inability to provide informed consent
* Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia \[AIN\]) within 4 months of study entry
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Elizabeth Chiao
Role: PRINCIPAL_INVESTIGATOR
AIDS Associated Malignancies Clinical Trials Consortium
Locations
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UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
Ucsf Ancre
San Francisco, California, United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Weill-Cornell Medical College
New York, New York, United States
Laser Surgery Care Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
University of Puerto Rico Comprehensive Cancer Center
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2013-01637
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMC-084
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-084
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-084
Identifier Type: -
Identifier Source: org_study_id
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