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

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00711815
First received: July 3, 2008
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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
HPV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of HPV Clearance: A Prospective Study

Further study details as provided by University of Alabama at Birmingham:

Biospecimen Retention:   Samples With DNA

Whole blood, cervical cells


Enrollment: 197
Study Start Date: January 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
UA
HPV positive

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 3, 2008
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 13, 2013