Clinical Trial: Anal Cancer Screening Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Anal Cancer Screening Study
Brief Summary:
Background:
- HIV-positive men who have sex with men (MSM) have rates of anal cancer that approach those of cervical cancer in women. However, unlike cervical cancer, there is no current recommended method of screening that could be used to detect anal precancerous lesions for the prevention of anal cancer in HIV-positive MSM.
- Infections by human papillomavirus (HPV) are the likely cause of cervical and anal precancer and cancer. Detecting the presence of HPV or related biomarkers has helped to identify women who may be at increased risk of cervical cancer; researchers believe that early detection of HPV or related biomarkers in MSM may be useful for anal cancer screening.
Objectives:
- To evaluate the effectiveness of various tests to detect cancer-causing HPV in HIV-positive men who have sex with men.
Eligibility:
- HIV-positive MSM that are interested in receiving anal screening for precancer
Design:
- HIV-positive MSM will respond to a self-administered risk factor questionnaire, and will undergo a physical exam and a high-resolution anoscopy at the participating clinic.
- The clinician will then collect to anal Pap specimens from each subject for research on HPV and related biomarkers.
- Participants will be followed annually for 2 years to collect additional health data for research follow-up.
Detailed Summary:
BACKGROUND:
Human immunodeficiency virus (HIV) positive men who have sex with men (MSM) are at risk of anal cancer that approaches the risk of cervical cancer for unscreened women living in developing countries. There is currently no accepted method for screening HIV positive MSM for anal precancer to reduce the morbidity and mortality due to anal cancer ; in the absence of a standard and effective screening modality, clinics often resort to anoscopy, a diagnostic procedure akin to colposcopy, and directed biopsies on all HIV positive MSM.
OBJECTIVE:
Evaluate the clinical performance of detecting carcinogenic human papillomavirus (HPV) DNA and RNA, individual carcinogenic HPV genotypes, cytogenetic markers, p16(INK4a) and Ki-67 immunocytochemistry staining, anal cytology, and combinations of these biomarkers for identifying HIV positive MSM with prevalent, 1 year cumulative, and 2 year cumulative anal precancer and cancer (histologically-confirmed greater than or equal to AIN3) using clinician-collected anal specimens at baseline.
ELIGIBILITY:
HIV positive MSM seeking anal cancer screening. Inclusion: 1) KPNC member; 2) documented HIV-positive status; 3) able and mentally competent to provide written, informed consent. Exclusion:A current diagnosis of anal cancer at enrollment.
DESIGN:
To address this need and to improve detection of anal precancer and cancer, we propose a screening cohort study of 1,000 HIV positive MSM participating in the Kaiser Permanente Northern California (KPNC) health maintenance program. Under written, informed consent, participating KPNC members will
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: High resolution anoscopy [ Time Frame: 1 to 2 years ]
Original Primary Outcome:
Current Secondary Outcome: Natural History of Anal HPV in HIV-positive men
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: June 4, 2009
Date Started: May 30, 2009
Date Completion:
Last Updated: April 21, 2017
Last Verified: August 24, 2016
