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Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

Primary Purpose

Anal Cancer, HIV Infection, Human Papilloma Virus Infection

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
comparison of screening methods
laboratory biomarker analysis
questionnaire administration
quality-of-life assessment
Sponsored by
AIDS Malignancy Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests
  • 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:

  • Current or history of anal or perianal carcinoma
  • 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

Sites / Locations

  • UCLA Clinical AIDS Research and Education (CARE) Center
  • Ucsf Ancre
  • John H. Stroger Hospital of Cook County
  • Boston University Cancer Research Center
  • Beth Israel Deaconess Medical Center
  • Montefiore Medical Center
  • Weill-Cornell Medical College
  • Laser Surgery Care Center
  • Wake Forest University Health Sciences
  • University of Pittsburgh School of Medicine
  • Baylor College of Medicine
  • University of Puerto Rico Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening (HSIL detection)

Arm Description

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.

Outcomes

Primary Outcome Measures

Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Prevalence of HSIL
The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL.
Sensitivity of Each of the Methods of APTIMA Assay at Baseline
Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive.
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases.

Secondary Outcome Measures

Acceptability of Anal Cancer Screening
Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy

Full Information

First Posted
September 17, 2013
Last Updated
April 26, 2023
Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01946139
Brief Title
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Official Title
Screening HIV-Infected Women for Anal Cancer Precursors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2013 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIDS Malignancy Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.
Detailed Description
PRIMARY OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, HIV Infection, Human Papilloma Virus Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening (HSIL detection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
comparison of screening methods
Intervention Description
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
Description
Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
Time Frame
at baseline
Title
Prevalence of HSIL
Description
The prevalence of HSIL will be estimated as the proportion of women who are HRA positive for HSIL at entry and its 95% confidence interval. Logistic regression analysis will be used to evaluate the association of potential risk factors with diagnosis of HSIL.
Time Frame
at baseline
Title
Sensitivity of Each of the Methods of APTIMA Assay at Baseline
Description
Among patients whose high resolution anoscopy (HRA) results were positive for HSIL and had APTIMA assays at baseline, the number whose APTIMA assay results were positive.
Time Frame
at baseline
Title
Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry
Description
The Poisson rate and its 95% confidence interval will be estimated from the number of HSIL cases detected divided by the cumulative years of follow-up across these cases.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Acceptability of Anal Cancer Screening
Description
Anal cancer screening is typically done using a high resolution anoscopy, a device which allows visualization of the anus. To determine if participants found anal screening acceptable, they were asked if they were at east with having a high resolution anoscopy. The results indicated the number of participants who felt at ease with having a high resolution anoscopy
Time Frame
at baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests 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: Current or history of anal or perianal carcinoma 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Chiao
Organizational Affiliation
AIDS Associated Malignancies Clinical Trials Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Clinical AIDS Research and Education (CARE) Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1793
Country
United States
Facility Name
Ucsf Ancre
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
John H. Stroger Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Weill-Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Laser Surgery Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Puerto Rico Comprehensive Cancer Center
City
San Juan
ZIP/Postal Code
00929-0134
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV

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