Anal Cancer Screening Study

November 5, 2020 updated by: National Cancer Institute (NCI)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 respond to a self-administered risk factor questionnaire and will undergo two anal specimen collections into liquid-based cytology (LBC) medium prior to a digital exam and high resolution anoscopy. Subjects will be asked to self-collect at home into the same LBC buffer and return their specimen in a prepared return envelope to evaluate the utility of self-collection for anal cancer screening. Subjects will be followed annually for two years to collect follow-up clinical data related to outcomes. Baseline clinician-collected specimens will be tested in a masked fashion for the following clinical biomarkers: 1) carcinogenic HPV DNA in aggregate and individual carcinogenic HPV genotypes; 2) carcinogenetic HPV RNA and HPV16/18 RNA; 3) cytogentic changes (3q, 5p, and 20q amplification); and 4) p16(INK4a) and Ki-67 immunocytochemical staining. For reference, clinician-collected specimens will be used to make LBC slides and evaluated by an expert cytopathology laboratory. We will estimate the clinical performance (sensitivity, specificity, positive and negative predictive values, and referral rates) for detection of prevalently-detected, one-year cumulative, and two-year cumulative histologically-confirmed anal precancer (anal intraepithelial neoplasia grade 3) or worse (greater than or equal to AIN3). We will test the self-collected anal specimens by the best molecular test(s) or combination of tests for detection of prevalently-detected greater than or equal to AIN3 as determined from testing the clinician-collected specimens. All MSM will undergo diagnostic procedures at all visits and independent of testing results, which will result in unbiased disease ascertainment.

Study Type

Observational

Enrollment (Actual)

363

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Human immunodeficiency virus (HIV) positive adult men who have sex with men that are members of KPNC (Kaiser Permanente Northern California) and do not have a current anal cancer diagnosis.@@@

Description

  • 2.1 ELIGIBILITY CRITERIA:

Any male member of KPNC who is 1) identified as HIV positive through the Kaiser HIV registry, 2) 18 years or older, can provide written, informed consent, and 3) is not currently diagnosed with anal cancer (prior to enrollment).

2.2 INCLUSION CRITERIA:

HIV-positive men will be invited to participate, regardless of race and ethnicity, as described below if they meet the eligibility criteria. Other than having been diagnosed with anal cancer prior to enrollment, there will no other disease-based exclusions. Because of the high fraction of HIV-positive men are in fact MSM, we will not prescreen men for their sexual orientation.

2.3 EXCLUSION CRITERIA:

The exclusion criteria will be age less than 18, a current diagnosis of anal cancer rendered prior to enrollment, an unwillingness or inability (evident mental incapacity to understand the informed consent documents) to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Human immunodeficiency virus (HIV) positive adult men who have sex with men that are members of KPNC (Kaiser Permanente Northern California) and do not have a current anal cancer diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High resolution anoscopy
Time Frame: 1 to 2 years
Detection of AIN2 and AIN3 in high resolution anoscopy
1 to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2009

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

November 4, 2020

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 5, 2009

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999909158
  • 09-C-N158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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