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

• ClinicalTrials.gov Identifier: NCT00709891
• Recruitment Status: Completed
• First Posted: July 3, 2008
• Results First Posted: February 9, 2015
• Last Update Posted: February 9, 2015
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: June 30, 2008
• First Posted Date: July 3, 2008
• Results First Submitted Date: January 20, 2015
• Results First Posted Date: February 9, 2015
• Last Update Posted Date: February 9, 2015
• Study Start Date: May 2008
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 5, 2015)

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.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: February 5, 2015)

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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: Human Papilloma Virus (HPV)
• Intervention: Device: cobas® 4800 HPV Test

Study Arms

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.

Intervention: Device: cobas® 4800 HPV Test

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 25, 2013): 47208
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00709891
• Other Study ID Numbers: RD000649; MWP-HPV-159 ( Other Identifier: Roche Molecular Systems, Inc. )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Clinical Trials, Hoffmann-La Roche
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Catherine Behrens; Roche Molecular Systems, Inc

• PRS Account: Hoffmann-La Roche
• Verification Date: February 2015