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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 30, 2008
Last updated: February 5, 2015
Last verified: February 2015
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.

Condition Intervention
Human Papilloma Virus (HPV) Device: cobas® 4800 HPV Test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With a Diagnosis of ≥ CIN2 [ Time Frame: Baseline to the end of the Baseline period (up to 12 weeks) ]
    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.

Secondary Outcome Measures:
  • Percentage of Participants With a Diagnosis of ≥ CIN3 [ Time Frame: Baseline to the end of the study (up to 5 years, 1 month) ]
    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.

Enrollment: 47208
Study Start Date: May 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: cobas® 4800 HPV Test


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00709891

  Hide Study Locations
United States, Alabama
Enterprise, Alabama, United States, 36331
Hoover, Alabama, United States, 35216
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85015
Phoenix, Arizona, United States, 85032
Tucson, Arizona, United States, 85712
Tucson, Arizona, United States, 85755
United States, California
Beverly Hills, California, United States, 90211
Carmichael, California, United States, 95608
Costa Mesa, California, United States, 92617
Fountain Valley, California, United States, 92708-5153
San Diego, California, United States, 92123
United States, Colorado
Colorado Springs, Colorado, United States, 80910
Lakewood, Colorado, United States, 80228
United States, Florida
Boynton Beach, Florida, United States, 8188
Ft. Lauderdale, Florida, United States, 33316
Jacksonville, Florida, United States, 32216
Jacksonville, Florida, United States, 32259
Jupiter, Florida, United States, 33458
Lake Worth, Florida, United States, 33461
Miami, Florida, United States, 33143
North Miami, Florida, United States, 33161
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33613
West Palm Beach, Florida, United States, 33401
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta, Georgia, United States, 30328
Decatur, Georgia, United States, 30033
Roswell, Georgia, United States, 30075
United States, Idaho
Boise, Idaho, United States, 83712
United States, Illinois
Champaign, Illinois, United States, 61820
United States, Indiana
Indianapolis, Indiana, United States, 46268
Newburgh, Indiana, United States, 47360
United States, Kentucky
Louisville, Kentucky, United States, 40291
Paducah, Kentucky, United States, 42003
United States, Louisiana
Covington, Louisiana, United States, 70433
Ruston, Louisiana, United States, 71270
United States, Michigan
Saginaw, Michigan, United States, 48604
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
Moorestown, New Jersey, United States, 08057
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
New Bern, North Carolina, United States, 28562
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Englewood, Ohio, United States, 45342
United States, Pennsylvania
Lansdale, Pennsylvania, United States, 19446
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Columbia, South Carolina, United States, 29201
Hilton Head, South Carolina, United States, 29926
North Charleston, South Carolina, United States, 29406
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Johnson City, Tennessee, United States, 37604
Nashville, Tennessee, United States, 37203
United States, Texas
Corpus Christi, Texas, United States, 78414
Dallas, Texas, United States, 75230
Houston, Texas, United States, 77054
McAllen, Texas, United States, 78503
Temple, Texas, United States, 76508
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Virginia Beach, Virginia, United States, 23456
United States, Washington
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Catherine Behrens Roche Molecular Systems, Inc
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00709891     History of Changes
Other Study ID Numbers: RD000649
MWP-HPV-159 ( Other Identifier: Roche Molecular Systems, Inc. )
Study First Received: June 30, 2008
Results First Received: January 20, 2015
Last Updated: February 5, 2015

Additional relevant MeSH terms:
Uterine Cervical Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Diseases
Genital Diseases, Female processed this record on September 19, 2017