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:
Thai Red Cross AIDS Research Centre
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
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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 |
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 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 |
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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
No Contacts or Locations Provided
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 |