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
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus (HPV)||Device: cobas® 4800 HPV Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47208 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||May 2008|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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.
Device: cobas® 4800 HPV Test
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709891
|Study Director:||Catherine Behrens||Roche Molecular Systems, Inc|