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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:
Hoffmann-La Roche
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
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| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | June 30, 2008 | |||
| Last Updated Date | February 5, 2015 | |||
| Start Date ICMJE | May 2008 | |||
| Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00709891 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease | |||
| Official Title ICMJE | 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 ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Human Papilloma Virus (HPV) | |||
| Intervention ICMJE | 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 |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 47208 | |||
| Completion Date | June 2013 | |||
| Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00709891 | |||
| Other Study ID Numbers ICMJE | RD000649 MWP-HPV-159 ( Other Identifier: Roche Molecular Systems, Inc. ) |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Hoffmann-La Roche | |||
| Study Sponsor ICMJE | Hoffmann-La Roche | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Hoffmann-La Roche | |||
| Verification Date | February 2015 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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