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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
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
Enrollment 47208
Recruitment Details  
Pre-assignment Details Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.
Arm/Group Title Cobas® 4800 HPV Test
Hide Arm/Group Description 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.
Period Title: Baseline, Cross-sectional Phase
Started 47208
Completed 45758
Not Completed 1450
Period Title: Longitudinal Follow-up Phase
Started 10002 [1]
Completed 5020
Not Completed 4982
[1]
Only participants who met study criteria in the Baseline phase started the Follow-up phase.
Arm/Group Title Cobas® 4800 HPV Test
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 46887
Hide Baseline Analysis Population Description
Eligible population: All participants who met the study inclusion/exclusion criteria, had not been enrolled in the study previously, and had not withdrawn consent before undergoing any study procedures. Of the enrolled population, 321 participants did not meet these criteria.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46887 participants
39.8  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46887 participants
Female
46887
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With a Diagnosis of ≥ CIN2
Hide Description 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.
Time Frame Baseline to the end of the Baseline period (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).
Arm/Group Title Cobas® 4800 HPV Test
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1578
Measure Type: Number
Unit of Measure: Percentage of participants
Positive cobas 4800 HPV test result - n=514 14.0
Negative cobas 4800 HPV test result - n=1064 0.8
2.Secondary Outcome
Title Percentage of Participants With a Diagnosis of ≥ CIN3
Hide Description 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.
Time Frame Baseline to the end of the study (up to 5 years, 1 month)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable ASC-US participant population: All enrolled participants with a diagnosis of atypical squamous cells of undetermined significance (ASC-US).
Arm/Group Title Cobas® 4800 HPV Test
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1578
Measure Type: Number
Unit of Measure: Percentage of participants
Positive cobas 4800 HPV test result - n=514 8.4
Negative cobas 4800 HPV test result - n=1064 0.3
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population: All enrolled participants. Non-serious adverse events were not recorded in this study.
 
Arm/Group Title Cobas® 4800 HPV Test
Hide Arm/Group Description 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.
All-Cause Mortality
Cobas® 4800 HPV Test
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Cobas® 4800 HPV Test
Affected / at Risk (%)
Total   1/47208 (0.00%) 
Vascular disorders   
Urogenital haemorrhage  1  1/47208 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cobas® 4800 HPV Test
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00709891    
Other Study ID Numbers: RD000649
MWP-HPV-159 ( Other Identifier: Roche Molecular Systems, Inc. )
First Submitted: June 30, 2008
First Posted: July 3, 2008
Results First Submitted: January 20, 2015
Results First Posted: February 9, 2015
Last Update Posted: February 9, 2015