Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
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ClinicalTrials.gov Identifier: NCT00709891 |
Recruitment Status :
Completed
First Posted : July 3, 2008
Results First Posted : February 9, 2015
Last Update Posted : February 9, 2015
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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.
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Baseline Characteristics
Arm/Group Title | Cobas® 4800 HPV Test | |
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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 | |
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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participants who met the study inclusion/exclusion criteria, had not been enrolled in the study previously, and had not withdrawn consent before undergoing any study procedures.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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 46887 participants | |
39.8 (12.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 46887 participants | |
Female |
46887 100.0%
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Male |
0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800 821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |