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Human Papilloma Virus DNA Self-Test

NCT ID: NCT00266266

Last Updated: 2017-12-29

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

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-10-31

Brief Summary

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HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

Detailed Description

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Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

Conditions

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Papilloma Virus, Human

Keywords

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Human Papilloma Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Exclusion Criteria

Less than 18 years old

Prior hysterectomy

Pregnancy

Use of corticosteroids

HIV positive
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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James Graham Brown Cancer Center

OTHER

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Edwards, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville,James Graham Brown Cancer Center

Locations

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James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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529.03

Identifier Type: -

Identifier Source: org_study_id