Status:
COMPLETED
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Human Papilloma Virus (HPV)
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief 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 appro...
Eligibility Criteria
Inclusion
- Females ≥ 21 years of age presenting for routine cervical cancer screening.
- An intact cervix.
- Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.
Exclusion
- Known pregnancy at study Visit 1.
- Presenting for colposcopy at study Visit 1.
- Any condition resulting in increased risk of bleeding at biopsy.
- Hysterectomy.
- Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
47208 Patients enrolled
Trial Details
Trial ID
NCT00709891
Start Date
May 1 2008
End Date
June 1 2013
Last Update
February 9 2015
Active Locations (61)
Enter a location and click search to find clinical trials sorted by distance.
1
Enterprise, Alabama, United States, 36331
2
Hoover, Alabama, United States, 35216
3
Mobile, Alabama, United States, 36608
4
Phoenix, Arizona, United States, 85015