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

Completed · Not applicable

Conditions studied: Human Papilloma Virus (HPV)

In brief

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.

Key facts

Study ID

NCT00709891

Run by

Hoffmann-La Roche

People needed

47208

Starts

2008-05-01

Expected to finish

2013-06-01

Last updated by the study team

2015-02-09

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Carmichael, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Fountain Valley, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Enterprise, Alabama, United States

Full record on ClinicalTrials.gov

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