Human Papilloma Virus (HPV) Clinical Trial
Official title:
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00715234 -
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
|
N/A | |
| Completed |
NCT03987490 -
Usability of HPV Vaccine Reminders
|
N/A |