Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
2 other identifiers
interventional
47,208
1 country
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Longer than P75 for not_applicable
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
February 9, 2015
CompletedFebruary 9, 2015
February 1, 2015
5.1 years
June 30, 2008
January 20, 2015
February 5, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Diagnosis of ≥ CIN2
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.
Baseline to the end of the Baseline period (up to 12 weeks)
Secondary Outcomes (1)
Percentage of Participants With a Diagnosis of ≥ CIN3
Baseline to the end of the study (up to 5 years, 1 month)
Study Arms (1)
cobas® 4800 HPV Test
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Unknown Facility
Enterprise, Alabama, 36331, United States
Unknown Facility
Hoover, Alabama, 35216, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Phoenix, Arizona, 85015, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Tucson, Arizona, 85755, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Costa Mesa, California, 92617, United States
Unknown Facility
Fountain Valley, California, 92708-5153, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Colorado Springs, Colorado, 80910, United States
Unknown Facility
Lakewood, Colorado, 80228, United States
Unknown Facility
Boynton Beach, Florida, 8188, United States
Unknown Facility
Fort Lauderdale, Florida, 33316, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Jacksonville, Florida, 32259, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Lake Worth, Florida, 33461, United States
Unknown Facility
Miami, Florida, 33143, United States
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North Miami, Florida, 33161, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33613, United States
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West Palm Beach, Florida, 33401, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
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Atlanta, Georgia, 30328, United States
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Decatur, Georgia, 30033, United States
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Roswell, Georgia, 30075, United States
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Boise, Idaho, 83712, United States
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Champaign, Illinois, 61820, United States
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Indianapolis, Indiana, 46268, United States
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Newburgh, Indiana, 47360, United States
Unknown Facility
Louisville, Kentucky, 40291, United States
Unknown Facility
Paducah, Kentucky, 42003, United States
Unknown Facility
Covington, Louisiana, 70433, United States
Unknown Facility
Ruston, Louisiana, 71270, United States
Unknown Facility
Saginaw, Michigan, 48604, United States
Unknown Facility
Las Vegas, Nevada, 89106, United States
Unknown Facility
Lawrenceville, New Jersey, 08648, United States
Unknown Facility
Moorestown, New Jersey, 08057, United States
Unknown Facility
Albuquerque, New Mexico, 87102, United States
Unknown Facility
New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27103, United States
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Englewood, Ohio, 45342, United States
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Lansdale, Pennsylvania, 19446, United States
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West Reading, Pennsylvania, 19611, United States
Unknown Facility
Columbia, South Carolina, 29201, United States
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Hilton Head, South Carolina, 29926, United States
Unknown Facility
North Charleston, South Carolina, 29406, United States
Unknown Facility
Chattanooga, Tennessee, 37404, United States
Unknown Facility
Johnson City, Tennessee, 37604, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Houston, Texas, 77054, United States
Unknown Facility
McAllen, Texas, 78503, United States
Unknown Facility
Temple, Texas, 76508, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
Unknown Facility
Virginia Beach, Virginia, 23456, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Related Publications (3)
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.
PMID: 25667973DERIVEDWright 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.
PMID: 24122508DERIVEDCastle 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.
PMID: 21865084DERIVED
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Catherine Behrens
Roche Molecular Systems, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2008
First Posted
July 3, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 9, 2015
Results First Posted
February 9, 2015
Record last verified: 2015-02