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

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ClinicalTrials.gov Identifier: NCT01637298
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : May 9, 2017
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

Study Description
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Brief 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.

Condition or disease
Anal Intraepithelial Neoplasia

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.

Study Design
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Study Type : Observational
Actual Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Thai Red Cross AIDS Research Centre
Study Start Date : December 2009
Actual Primary Completion Date : August 2015
Actual Study Completion Date : May 2017
Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Thai Red Cross AIDS Research Centre
ClinicalTrials.gov Identifier: NCT01637298     History of Changes
Other Study ID Numbers: AIN Study
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 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