Clinical trialNCT00709891CompletedInterventional

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

SponsorHoffmann-La RocheEnrollment47,208Human Papilloma Virus (HPV)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Catherine Behrens
Roche Molecular Systems, Inc
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

61 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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Enterprise, Alabama, United States
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Hoover, Alabama, United States
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Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Costa Mesa, California, United States
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Fountain Valley, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Lakewood, Colorado, United States
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Boynton Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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North Miami, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Roswell, Georgia, United States
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Boise, Idaho, United States
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Champaign, Illinois, United States
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Indianapolis, Indiana, United States
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Newburgh, Indiana, United States
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Louisville, Kentucky, United States
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Paducah, Kentucky, United States
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Covington, Louisiana, United States
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Ruston, Louisiana, United States
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Saginaw, Michigan, United States
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Las Vegas, Nevada, United States
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Lawrenceville, New Jersey, United States

21 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 May 2008
Primary completion: 30 Jun 2013
Completion: 30 Jun 2013
Last update posted: 9 Feb 2015
Registered enrollment: 47,208
Registry id: NCT00709891

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.