Human Papilloma Virus DNA Self-Test

Completed

• Conditions: Papilloma Virus, Human

• Registration Number: NCT00266266
• Lead Sponsor: University of Louisville

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-12-15
• Study First Submitted QC: 2005-12-15
• Study First Posted: 2005-12-16
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV DNA self-testing device to detect disease in patients with abnormal Pap smear	Patient will self-test immediately prior to their standard physician papsmear	To assess the concordance of HPV DNA self-testing device to detect disease in patients with abnormal Pap smear. Patients with a positive HPV Self-test by vaginal swab or vaginal tampon will be compared to the physician test results for concordance. Following patient self-sample collection, physician will collect cervical samples using a spatula. A self testing device which patients can use at their convenience will be beneficial in decreasing the incidence of cervical cancer in Kentucky.

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States