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

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: February 5, 2015
Last verified: February 2015
History of Changes
Results First Received: January 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Human Papilloma Virus (HPV)
Intervention: Device: cobas® 4800 HPV Test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had not met the study primary clinical endpoint of ≥ CIN2 were invited to participate in the longitudinal follow-up phase.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

 Period 1:   Baseline, Cross-sectional Phase
    Cobas® 4800 HPV Test  
STARTED     47208  
COMPLETED     45758  
NOT COMPLETED     1450  

Period 2:   Longitudinal Follow-up Phase
    Cobas® 4800 HPV Test  
STARTED     10002 [1]
COMPLETED     5020  
NOT COMPLETED     4982  
[1] Only participants who met study criteria in the Baseline phase started the Follow-up phase.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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participants who met the study inclusion/exclusion criteria, had not been enrolled in the study previously, and had not withdrawn consent before undergoing any study procedures.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.

Reporting Groups
  Description
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.

Baseline Measures
    Cobas® 4800 HPV Test  
Number of Participants  
[units: participants]
 		  46887  
Age  
[units: years]
Mean (Standard Deviation) 		  39.8  (12.3)  
Gender  
[units: participants]
 		 
Female     46887  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Diagnosis of ≥ CIN2   [ Time Frame: Baseline to the end of the Baseline period (up to 12 weeks) ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With a Diagnosis of ≥ CIN3   [ Time Frame: Baseline to the end of the study (up to 5 years, 1 month) ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


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 ( Other Identifier: Roche Molecular Systems, Inc. )
Study First Received: June 30, 2008
Results First Received: January 20, 2015
Last Updated: February 5, 2015
Health Authority: United States: Institutional Review Board