Spots Global Cancer Trial Database for Human Papilloma Virus DNA Self-Test
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Trial Identification
Brief Title: Human Papilloma Virus DNA Self-Test
Official Title: Human Papilloma Virus DNA Self-Test
Study ID: NCT00266266
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Contact Details
Name: Robert Edwards, MD
Affiliation: University of Louisville,James Graham Brown Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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