Human Papilloma Virus DNA Self-Test (HPV)
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Purpose
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?
| Condition |
|---|
|
Papilloma Virus, Human |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Human Papilloma Virus DNA Self-Test |
- 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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 171 |
| Study Start Date: | January 2004 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Abnormal pap smear ASCUS or higher
Age 18-postmenopausal
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
Contacts and Locations| United States, Kentucky | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | Robert Edwards, MD | University of Louisville,James Graham Brown Cancer Center |
More Information
No publications provided
| Responsible Party: | James Graham Brown Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00266266 History of Changes |
| Other Study ID Numbers: | 529.03 |
| Study First Received: | December 15, 2005 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by James Graham Brown Cancer Center:
|
Human Papilloma Virus |
Additional relevant MeSH terms:
|
Papilloma Virus Diseases Neoplasms, Squamous Cell |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013