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

HIV Infection Clinical Trial

Official title:

Screening HIV-Infected Women for Anal Cancer Precursors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946139
• Other study ID #: AMC-084
• Secondary ID: NCI-2013-01637AM
• Status: Completed
• Phase: N/A
• Start date: December 4, 2013
• Est. completion date: October 31, 2018

Study information

• Verified date: April 2023
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Communicable Diseases
• HIV Infection
• Human Papilloma Virus Infection
• Infections
• Papilloma
• Papillomavirus Infections

Intervention

Procedure:
• comparison of screening methods
Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays

Other:
• laboratory biomarker analysis
Correlative studies
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Comprehensive Cancer Center	San Juan
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	UCLA Clinical AIDS Research and Education (CARE) Center	Los Angeles	California
United States	Laser Surgery Care Center	New York	New York
United States	Weill-Cornell Medical College	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Ucsf Ancre	San Francisco	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline
Primary	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.	at baseline
Primary	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.	at baseline
Primary	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.	Up to 2 years
Secondary	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	at baseline