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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00711815 |
This is a research study looking at gene characteristics in blood and Pap smear samples in hopes of identifying markers that will predict if the HPV infection is present or not.
Condition |
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HPV Infections |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Biomarkers of HPV Clearance: A Prospective Study |
Whole blood, cervical cells
Estimated Enrollment: | 200 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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UA
HPV positive
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Because infection with high-risk human papillomavirus is a necessary cause of cervical cancer, HPV testing has many potential uses in cervical cancer screening. Unfortunately, like cytology, it suffers from a lack of specificity when used for population-based screening. Given that HPV testing detects more cases of CIN3+ than cytology and that it would probably be more practical in developing regions, finding a biomarker that would increase specificity has been the goal for much research on HPV and cervical cancer. The goal of this study is to explore potential predictors of viral clearance, specifically RNA levels of candidate genes in cervical swabs and host genetic polymorphisms, in the context of genotype-specific infection data.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35205 |
Principal Investigator: | Warner K Huh, M.D. | University of Alabama at Birmingham |
Responsible Party: | UAB ( Warner K. Huh, M.D. ) |
Study ID Numbers: | W061101002 (UAB 0626), 20062154 (WIRB), T06020012 |
Study First Received: | July 3, 2008 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00711815 History of Changes |
Health Authority: | United States: Institutional Review Board |
Women of the state of Alabama CIN 1 negative biopsy normal colposcopy HPV |
Infection |