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A Study to Identify Markers in Blood and Tissue of HPV Clearance

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ClinicalTrials.gov Identifier: NCT00711815
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : August 5, 2011
Sponsor:
Information provided by:
University of Alabama at Birmingham

Brief Summary:
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 or disease
HPV Infections

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of HPV Clearance: A Prospective Study
Study Start Date : January 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Group/Cohort
UA
HPV positive



Biospecimen Retention:   Samples With DNA
Whole blood, cervical cells


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HPV-positive women with biopsy-confirmed CIN 1 or negative biopsies or normal colposcopic findings
Criteria

Inclusion Criteria:

  • HPV positive

Exclusion Criteria:

  • Negative for HPV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711815


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Warner K Huh, M.D. University of Alabama at Birmingham

Responsible Party: Warner K. Huh, M.D., UAB
ClinicalTrials.gov Identifier: NCT00711815     History of Changes
Other Study ID Numbers: W061101002 (UAB 0626)
20062154 (WIRB)
T06020012
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011

Keywords provided by University of Alabama at Birmingham:
Women of the state of Alabama
CIN 1
negative biopsy
normal colposcopy
HPV

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections