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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Condition or disease | Intervention/treatment | Phase |
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Human Papilloma Virus (HPV) | Device: cobas® 4800 HPV Test | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47208 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Diagnostic |
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 |

Arm | Intervention/treatment |
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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.
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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.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Females ≥ 21 years of age presenting for routine cervical cancer screening.
- An intact cervix.
- Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.
Exclusion Criteria:
- Known pregnancy at study Visit 1.
- Presenting for colposcopy at study Visit 1.
- Any condition resulting in increased risk of bleeding at biopsy.
- Hysterectomy.
- Known history of ablative or excisional therapy to the cervix within the preceding 12 months.

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 |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00709891 |
Other Study ID Numbers: |
RD000649 MWP-HPV-159 ( Other Identifier: Roche Molecular Systems, Inc. ) |
First Posted: | July 3, 2008 Key Record Dates |
Results First Posted: | February 9, 2015 |
Last Update Posted: | February 9, 2015 |
Last Verified: | February 2015 |
Papilloma Uterine Cervical Diseases Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Uterine Diseases |