NCT00709891

Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease

Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47,208 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Human Papilloma Virus (HPV)

Interventions

Type	Name	Description
DEVICE	cobas® 4800 HPV Test

Timeline

• Start date: 2008-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2008-07-03
• Last updated: 2015-02-09
• Results posted: 2015-02-09

Locations

61 sites across 1 country: United States