Clinical trial NCT00709891: Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
Official title: Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus (HPV)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 47208
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Percentage of Participants With a Diagnosis of ≥ CIN2
timeFrame: Baseline to the end of the Baseline period (up to 12 weeks)
Secondary outcomes:
measure: Percentage of Participants With a Diagnosis of ≥ CIN3
timeFrame: Baseline to the end of the study (up to 5 years, 1 month)
Other outcomes:
Locations:
city: Enterprise
country: United States
state: Alabama
city: Hoover
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Lakewood
country: United States
state: Colorado
city: Boynton Beach
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Champaign
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Newburgh
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Paducah
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Ruston
country: United States
state: Louisiana
city: Saginaw
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Lawrenceville
country: United States
state: New Jersey
city: Moorestown
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New Bern
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Englewood
country: United States
state: Ohio
city: Lansdale
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Hilton Head
country: United States
state: South Carolina
city: North Charleston
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Virginia Beach
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Roche Molecular Systems, Inc
name: Catherine Behrens
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.