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Clinical Trial 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?


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00266266
Study type Observational
Source University of Louisville
Contact
Status Completed
Phase N/A
Start date January 2004
Completion date October 2008

See also
  Status Clinical Trial Phase
Completed NCT01206556 - IMPAACT P1085: Human Papilloma Virus (HPV) Type-Specific Antibody N/A