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

NCT ID: NCT00711815

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HPV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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UA

HPV positive

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* HPV positive

Exclusion Criteria

* Negative for HPV
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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UAB

Principal Investigators

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Warner K Huh, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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20062154 (WIRB)

Identifier Type: -

Identifier Source: secondary_id

T06020012

Identifier Type: -

Identifier Source: secondary_id

W061101002 (UAB 0626)

Identifier Type: -

Identifier Source: org_study_id

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