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: July 10, 2012

Last verified: July 2012

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer HIV/AIDS

U.S. FDA Resources

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

Enrollment:	450
Study Start Date:	December 2009

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
Genders 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

No Contacts or Locations Provided

More Information

No publications provided

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:	July 10, 2012
Health Authority:	Thailand: Ethical Committee

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 May 19, 2013

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