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Anal Cancer Screening Study

NCT00914537 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 363

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nicolas Wentzensen, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-02
Primary Completion
2020-11-04
Completion
2020-11-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00914537 on ClinicalTrials.gov