Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening Using Cervical Samples Prepared With the COBAS X421 Instrument

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00709891
First received: June 30, 2008
Last updated: August 26, 2014
Last verified: June 2010
  Purpose

This study will provide data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase will be conducted with approximately 45,000 women undergoi ng routine cervical cancer screening, of whom 7,400 will be selected to undergo colposcopy and biopsy/ECC at baseline. These subjects will include women with cy tology that is 'not normal' and a selection of those with 'normal' cytology who will enter a follow-up phase and undergo cytological evaluation annually for 3 y ears. In this follow up phase, colposcopy, biopsy/ECC will be 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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 Using Cervical Samples Prepared With the COBAS X421 Instrument

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • The clinical endpoint of greater than or equal to CIN2 includes histology results of CIN2, CIN3, cervical cancer, or ACIS [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The clinical endpoint of greater than or equal to CIN3 includes any histology results of CIN3, cervical cancer, or ACIS [ Time Frame: Study duration ] [ Designated as safety issue: No ]

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: A Device: Cobas® 4800 HPV Test

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ECC 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 ClinicalTrials.gov identifier: NCT00709891

  Hide Study Locations
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, 32259
Jacksonville, Florida, United States, 32216
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
Investigators
Study Director: Catherine Behrens Roche Molecular Systems, Inc
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00709891     History of Changes
Other Study ID Numbers: RD000649, MWP_HPV_159
Study First Received: June 30, 2008
Last Updated: August 26, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Papilloma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 11, 2014