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

NCT ID: NCT00709891

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-06-30

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.

Conditions

Human Papilloma Virus (HPV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

cobas® 4800 HPV Test

Intervention Type: DEVICE

Interventions

cobas® 4800 HPV Test

Intervention Type: DEVICE

Eligibility 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 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Behrens

Role: STUDY_DIRECTOR

Roche Molecular Systems, Inc

Locations

Enterprise, Alabama, United States

Hoover, Alabama, United States

Mobile, Alabama, United States

Phoenix, Arizona, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Tucson, Arizona, United States

Beverly Hills, California, United States

Carmichael, California, United States

Costa Mesa, California, United States

Fountain Valley, California, United States

San Diego, California, United States

Colorado Springs, Colorado, United States

Lakewood, Colorado, United States

Boynton Beach, Florida, United States

Fort Lauderdale, Florida, United States

Jacksonville, Florida, United States

Jacksonville, Florida, United States

Jupiter, Florida, United States

Lake Worth, Florida, United States

Miami, Florida, United States

North Miami, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

West Palm Beach, Florida, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Roswell, Georgia, United States

Boise, Idaho, United States

Champaign, Illinois, United States

Indianapolis, Indiana, United States

Newburgh, Indiana, United States

Louisville, Kentucky, United States

Paducah, Kentucky, United States

Covington, Louisiana, United States

Ruston, Louisiana, United States

Saginaw, Michigan, United States

Las Vegas, Nevada, United States

Lawrenceville, New Jersey, United States

Moorestown, New Jersey, United States

Albuquerque, New Mexico, United States

New Bern, North Carolina, United States

Winston-Salem, North Carolina, United States

Englewood, Ohio, United States

Lansdale, Pennsylvania, United States

West Reading, Pennsylvania, United States

Columbia, South Carolina, United States

Hilton Head, South Carolina, United States

North Charleston, South Carolina, United States

Chattanooga, Tennessee, United States

Johnson City, Tennessee, United States

Nashville, Tennessee, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Houston, Texas, United States

McAllen, Texas, United States

Temple, Texas, United States

Salt Lake City, Utah, United States

Virginia Beach, Virginia, United States

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25667973 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24122508 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21865084 (View on PubMed)

Other Identifiers

MWP-HPV-159

Identifier Type: OTHER

Identifier Source: secondary_id

RD000649

Identifier Type: -

Identifier Source: org_study_id