Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
February 5, 2015 updated by: Hoffmann-La Roche
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47208
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Enterprise, Alabama, United States, 36331
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Hoover, Alabama, United States, 35216
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Mobile, Alabama, United States, 36608
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Arizona
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Phoenix, Arizona, United States, 85032
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Phoenix, Arizona, United States, 85015
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Tucson, Arizona, United States, 85712
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Tucson, Arizona, United States, 85755
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California
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Beverly Hills, California, United States, 90211
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Carmichael, California, United States, 95608
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Costa Mesa, California, United States, 92617
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Fountain Valley, California, United States, 92708-5153
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San Diego, California, United States, 92123
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Colorado
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Colorado Springs, Colorado, United States, 80910
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Lakewood, Colorado, United States, 80228
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Florida
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Boynton Beach, Florida, United States, 8188
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Ft. Lauderdale, Florida, United States, 33316
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32259
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Jupiter, Florida, United States, 33458
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Lake Worth, Florida, United States, 33461
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Miami, Florida, United States, 33143
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North Miami, Florida, United States, 33161
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Sarasota, Florida, United States, 34239
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Tampa, Florida, United States, 33613
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West Palm Beach, Florida, United States, 33409
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West Palm Beach, Florida, United States, 33401
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Georgia
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Atlanta, Georgia, United States, 30328
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Decatur, Georgia, United States, 30033
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Roswell, Georgia, United States, 30075
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Idaho
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Boise, Idaho, United States, 83712
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Illinois
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Champaign, Illinois, United States, 61820
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Indiana
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Indianapolis, Indiana, United States, 46268
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Newburgh, Indiana, United States, 47360
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Kentucky
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Louisville, Kentucky, United States, 40291
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Paducah, Kentucky, United States, 42003
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Louisiana
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Covington, Louisiana, United States, 70433
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Ruston, Louisiana, United States, 71270
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Michigan
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Saginaw, Michigan, United States, 48604
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Nevada
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Las Vegas, Nevada, United States, 89106
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
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Moorestown, New Jersey, United States, 08057
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New Mexico
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Albuquerque, New Mexico, United States, 87102
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North Carolina
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New Bern, North Carolina, United States, 28562
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Winston-Salem, North Carolina, United States, 27103
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Ohio
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Englewood, Ohio, United States, 45342
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Pennsylvania
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Lansdale, Pennsylvania, United States, 19446
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West Reading, Pennsylvania, United States, 19611
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South Carolina
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Columbia, South Carolina, United States, 29201
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Hilton Head, South Carolina, United States, 29926
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North Charleston, South Carolina, United States, 29406
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Tennessee
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Chattanooga, Tennessee, United States, 37404
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Johnson City, Tennessee, United States, 37604
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Nashville, Tennessee, United States, 37203
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Texas
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Corpus Christi, Texas, United States, 78414
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Dallas, Texas, United States, 75230
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Houston, Texas, United States, 77054
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McAllen, Texas, United States, 78503
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Temple, Texas, United States, 76508
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Utah
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Salt Lake City, Utah, United States, 84107
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Virginia
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Virginia Beach, Virginia, United States, 23456
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Washington
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Tacoma, Washington, United States, 98405
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: cobas® 4800 HPV Test
The cobas 4800 human papillomavirus (HPV) Test combines in a single assay the identification of pooled high-risk oncogenic HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), as well as genotypes 16 and 18 individually.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With a Diagnosis of ≥ CIN2
Time Frame: Baseline to the end of the Baseline period (up to 12 weeks)
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A diagnosis of ≥ CIN2 (cervical intraepithelial neoplasia) included histology results of CIN2, CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma.
The diagnosis was based on central pathology review.
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Baseline to the end of the Baseline period (up to 12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With a Diagnosis of ≥ CIN3
Time Frame: Baseline to the end of the study (up to 5 years, 1 month)
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A diagnosis of ≥ CIN3 (cervical intraepithelial neoplasia) included histology results of CIN3, adenocarcinoma in situ, squamous cell carcinoma, or adenocarcinoma.
The diagnosis was based on central pathology review.
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Baseline to the end of the study (up to 5 years, 1 month)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Catherine Behrens, Roche Molecular Systems, Inc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Monsonego J, Cox JT, Behrens C, Sandri M, Franco EL, Yap PS, Huh W. Prevalence of high-risk human papilloma virus genotypes and associated risk of cervical precancerous lesions in a large U.S. screening population: data from the ATHENA trial. Gynecol Oncol. 2015 Apr;137(1):47-54. doi: 10.1016/j.ygyno.2015.01.551. Epub 2015 Feb 8.
- Wright TC Jr, Stoler MH, Behrens CM, Sharma A, Sharma K, Apple R. Interlaboratory variation in the performance of liquid-based cytology: insights from the ATHENA trial. Int J Cancer. 2014 Apr 15;134(8):1835-43. doi: 10.1002/ijc.28514. Epub 2013 Oct 29.
- Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 2011 Sep;12(9):880-90. doi: 10.1016/S1470-2045(11)70188-7. Epub 2011 Aug 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
June 30, 2008
First Submitted That Met QC Criteria
July 2, 2008
First Posted (Estimate)
July 3, 2008
Study Record Updates
Last Update Posted (Estimate)
February 9, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD000649
- MWP-HPV-159 (Other Identifier: Roche Molecular Systems, Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.