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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00709891
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : February 9, 2015
Last Update Posted : February 9, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 30, 2008
First Posted Date  ICMJE July 3, 2008
Results First Submitted Date  ICMJE January 20, 2015
Results First Posted Date  ICMJE February 9, 2015
Last Update Posted Date February 9, 2015
Study Start Date  ICMJE May 2008
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2015)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Human Papilloma Virus (HPV)
Intervention  ICMJE Device: cobas® 4800 HPV Test
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2013)
47208
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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. )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Clinical Trials, Hoffmann-La Roche
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Catherine Behrens Roche Molecular Systems, Inc
PRS Account Hoffmann-La Roche
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP