Clinical Trial: Human Papilloma Virus DNA Self-Test

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Human Papilloma Virus DNA Self-Test

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 Summary: 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.
Sponsor: James Graham Brown Cancer Center

Current Primary Outcome: HPV DNA self-testing device to detect disease in patients with abnormal Pap smear [ Time Frame: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: James Graham Brown Cancer Center

Dates:
Date Received: December 15, 2005
Date Started: January 2004
Date Completion:
Last Updated: May 3, 2013
Last Verified: May 2013