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Completed Not applicable Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT00709891

Public ClinicalTrials.gov record NCT00709891. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00709891
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
47,208 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
21 Years and older
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2008 (Type not available)
Primary completion
Jun 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Feb 9, 2015

2008 – 2013

United States locations

U.S. sites
61
U.S. states
24
U.S. cities
57
Facility City State ZIP Site status
Not listed Enterprise Alabama 36331 —
Not listed Hoover Alabama 35216 —
Not listed Mobile Alabama 36608 —
Not listed Phoenix Arizona 85015 —
Not listed Phoenix Arizona 85032 —
Not listed Tucson Arizona 85712 —
Not listed Tucson Arizona 85755 —
Not listed Beverly Hills California 90211 —
Not listed Carmichael California 95608 —
Not listed Costa Mesa California 92617 —
Not listed Fountain Valley California 92708-5153 —
Not listed San Diego California 92123 —
Not listed Colorado Springs Colorado 80910 —
Not listed Lakewood Colorado 80228 —
Not listed Boynton Beach Florida 8188 —
Not listed Fort Lauderdale Florida 33316 —
Not listed Jacksonville Florida 32216 —
Not listed Jacksonville Florida 32259 —
Not listed Jupiter Florida 33458 —
Not listed Lake Worth Florida 33461 —
Not listed Miami Florida 33143 —
Not listed North Miami Florida 33161 —
Not listed Sarasota Florida 34239 —
Not listed Tampa Florida 33613 —
Not listed West Palm Beach Florida 33401 —
Not listed West Palm Beach Florida 33409 —
Not listed Atlanta Georgia 30328 —
Not listed Decatur Georgia 30033 —
Not listed Roswell Georgia 30075 —
Not listed Boise Idaho 83712 —
Not listed Champaign Illinois 61820 —
Not listed Indianapolis Indiana 46268 —
Not listed Newburgh Indiana 47360 —
Not listed Louisville Kentucky 40291 —
Not listed Paducah Kentucky 42003 —
Not listed Covington Louisiana 70433 —
Not listed Ruston Louisiana 71270 —
Not listed Saginaw Michigan 48604 —
Not listed Las Vegas Nevada 89106 —
Not listed Lawrenceville New Jersey 08648 —
Not listed Moorestown New Jersey 08057 —
Not listed Albuquerque New Mexico 87102 —
Not listed New Bern North Carolina 28562 —
Not listed Winston-Salem North Carolina 27103 —
Not listed Englewood Ohio 45342 —
Not listed Lansdale Pennsylvania 19446 —
Not listed West Reading Pennsylvania 19611 —
Not listed Columbia South Carolina 29201 —
Not listed Hilton Head South Carolina 29926 —
Not listed North Charleston South Carolina 29406 —
Not listed Chattanooga Tennessee 37404 —
Not listed Johnson City Tennessee 37604 —
Not listed Nashville Tennessee 37203 —
Not listed Corpus Christi Texas 78414 —
Not listed Dallas Texas 75230 —
Not listed Houston Texas 77054 —
Not listed McAllen Texas 78503 —
Not listed Temple Texas 76508 —
Not listed Salt Lake City Utah 84107 —
Not listed Virginia Beach Virginia 23456 —
Not listed Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00709891, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 9, 2015 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00709891 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →