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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
July 2, 2012
May 8, 2017
December 2009
August 2015   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01637298 on ClinicalTrials.gov Archive Site
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Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men
The Thai Red Cross AIDS Research Centre
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
MSM with HIV negative and positive in Thailand
Anal Intraepithelial Neoplasia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
May 2017
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • MSM with HIV negative
  • MSM with HIV positive
Sexes Eligible for Study: Male
18 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01637298
AIN Study
No
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Thai Red Cross AIDS Research Centre
Thai Red Cross AIDS Research Centre
  • University of California, San Francisco
  • South East Asia Research Collaboration with Hawaii
  • Chulalongkorn University
Not Provided
Thai Red Cross AIDS Research Centre
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP