Human Papilloma Virus DNA Self-Test
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
Observational Model: Cohort, Time Perspective: Prospective
HPV DNA self-testing device to detect disease in patients with abnormal Pap smear
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.
Patient will self-test immediately prior to their standard physician papsmear
Robert Edwards, MD
University of Louisville,James Graham Brown Cancer Center
United States: Food and Drug Administration
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|