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| Sponsor: | James Graham Brown Cancer Center |
|---|---|
| Collaborator: |
University of Louisville |
| Information provided by: | James Graham Brown Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00266266 |
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 |
| Official Title: | Human Papilloma Virus DNA Self-Test |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2005 (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 |
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
| Responsible Party: | James Graham Brown Cancer Center ( Lynn P. Parker, MD ) |
| Study ID Numbers: | 529.03 |
| Study First Received: | December 15, 2005 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00266266 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Human Papilloma Virus |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Squamous Cell Papilloma Neoplasms, Glandular and Epithelial |
