- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637298
Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men
May 8, 2017 updated by: Thai Red Cross AIDS Research Centre
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
450
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
MSM with HIV negative and positive in Thailand
Description
Inclusion Criteria:
- MSM with HIV negative
- MSM with HIV positive
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
July 2, 2012
First Submitted That Met QC Criteria
July 10, 2012
First Posted (Estimate)
July 11, 2012
Study Record Updates
Last Update Posted (Actual)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 8, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIN Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anal Intraepithelial Neoplasia
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Medtronic - MITGCompletedAnal Intraepithelial Neoplasia (AIN) | High-grade Squamous Intraepithelial Lesions (HSIL)United States
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Hospital Universitari Vall d'Hebron Research InstituteUnknown
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedHigh Grade Anal Canal Intraepithelial Neoplasia | High Grade Vulvar Squamous Intraepithelial LesionUnited States
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Academisch Medisch Centrum - Universiteit van Amsterdam...Leiden University Medical Center; ISA Pharmaceuticals B.V.CompletedHIV | Anal Intraepithelial NeoplasiaNetherlands
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European Institute of OncologyRecruitingAnal Cancer | High-Risk Cancer | Anal Intraepithelial Neoplasia 2 | Anal Intraepithelial Neoplasia 1Italy
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Johns Hopkins UniversityUniversity of Wisconsin, Madison; Frantz Viral Therapeutics, LLCCompletedPrecancerous Conditions | Human Papilloma Virus | Anal Dysplasia | HPV-Related Anal Intraepithelial Neoplasia | AIN2/3 | Artesunate | Alternative TreatmentUnited States
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Medtronic - MITGCompletedHIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial LesionsUnited States
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AIDS Malignancy ConsortiumNational Cancer Institute (NCI); The Emmes Company, LLC; Inovio PharmaceuticalsActive, not recruitingAnal Intraepithelial Neoplasia | High Grade Squamous Intraepithelial Neoplasia | HIV Positivity | Human Papillomavirus-16 Positive | Human Papillomavirus-18 PositiveUnited States, Puerto Rico
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University of Wisconsin, MadisonWisconsin Partnership ProgramRecruitingHigh-Grade Anal Intraepithelial NeoplasiaUnited States
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David FinchLancashire Teaching Hospitals NHS Foundation TrustNot yet recruitingAnal Intraepithelial Neoplasia | Anal High-grade Squamous Intraepithelial Lesion | Anal HSIL