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Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men

NCT01637298 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2017-05-09

No results posted yet for this study

Summary

The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Conditions

  • Anal Intraepithelial Neoplasia

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • SEARCH Research Foundation

    collaborator OTHER

  • Chulalongkorn University

    collaborator OTHER

  • Thai Red Cross AIDS Research Centre

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2015-08-31
Completion
2017-05-31

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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 NCT01637298 on ClinicalTrials.gov