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

This study has been completed.

Sponsor:

Collaborators:

University of California, San Francisco

South East Asia Research Collaboration with Hawaii

Chulalongkorn University

Information provided by (Responsible Party):

Thai Red Cross AIDS Research Centre

ClinicalTrials.gov Identifier:

NCT01637298

First received: July 2, 2012

Last updated: May 8, 2017

Last verified: May 2017

History of Changes

Purpose

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.

Condition
Anal Intraepithelial Neoplasia


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Thai Red Cross AIDS Research Centre

Further study details as provided by Thai Red Cross AIDS Research Centre:


Enrollment:	450
Study Start Date:	December 2009
Study Completion Date:	May 2017
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

MSM with HIV negative and positive in Thailand

Criteria

Inclusion Criteria:

MSM with HIV negative
MSM with HIV positive

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier:	NCT01637298 History of Changes
Other Study ID Numbers:	AIN Study
Study First Received:	July 2, 2012
Last Updated:	May 8, 2017

Keywords provided by Thai Red Cross AIDS Research Centre:


Histological HGAIN detected biomarkers MSM population HPV subtypes	AIN study HIV-positive and HIV-negative MSM anal cytology and biomarkers likelihood of AIN development at month 12 and yearly thereafter

Additional relevant MeSH terms:


Neoplasms Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on June 26, 2017

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