James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
Completed
NCT Number: NCT00266266
Human Papilloma Virus DNA Self-Test
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?
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
University of Louisville
Other
Collaborators
- James Graham Brown Cancer Center
Registry information
Acronym: HPV
Important dates
- Study start
- 2004
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Dec 16, 2005
- Registry last updated
- Dec 29, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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