Trials / Completed
CompletedNCT00266266
Human Papilloma Virus DNA Self-Test
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 171 (actual)
- Sponsor
- University of Louisville · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2004-01-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2005-12-16
- Last updated
- 2017-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00266266. Inclusion in this directory is not an endorsement.