Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266266
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2005-12-15
Brief Title:
Human Papilloma Virus DNA Self-Test
Sponsor:
University of Louisville
Organization:
University of Louisville
Study Overview
Official Title:
Human Papilloma Virus DNA Self-Test
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPV
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 manufacturers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None