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

Anal Intraepithelial Neoplasia Clinical Trial

Official title:

The Thai Red Cross AIDS Research Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637298
• Other study ID #: AIN Study
• Status: Completed
• Phase: N/A
• First received: July 2, 2012
• Last updated: May 8, 2017
• Start date: December 2009
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Thai Red Cross AIDS Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, MCM proteins, high-risk 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• MSM with HIV negative

• MSM with HIV positive

Related Conditions & MeSH terms

• Anal Intraepithelial Neoplasia
• Carcinoma in Situ
• Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Thai Red Cross AIDS Research Centre	Chulalongkorn University, South East Asia Research Collaboration with Hawaii, University of California, San Francisco