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

NCT00709891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47208

Last updated 2015-02-09

Study results available
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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

DEVICE

cobas® 4800 HPV Test

Sponsors & Collaborators

Principal Investigators

  • Catherine Behrens · Roche Molecular Systems, Inc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709891 on ClinicalTrials.gov