Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening Using Cervical Samples Prepared With the COBAS X421 Instrument

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00709891
First received: June 30, 2008
Last updated: August 26, 2014
Last verified: June 2010

June 30, 2008
August 26, 2014
May 2008
June 2013   (final data collection date for primary outcome measure)
The clinical endpoint of greater than or equal to CIN2 includes histology results of CIN2, CIN3, cervical cancer, or ACIS [ Time Frame: Study duration ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00709891 on ClinicalTrials.gov Archive Site
The clinical endpoint of greater than or equal to CIN3 includes any histology results of CIN3, cervical cancer, or ACIS [ Time Frame: Study duration ] [ Designated as safety issue: No ]
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Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening Using Cervical Samples Prepared With the COBAS X421 Instrument
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening Using Cervical Samples Prepared With the COBAS X421 Instrument

This study will provide data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase will be conducted with approximately 45,000 women undergoi ng routine cervical cancer screening, of whom 7,400 will be selected to undergo colposcopy and biopsy/ECC at baseline. These subjects will include women with cy tology that is 'not normal' and a selection of those with 'normal' cytology who will enter a follow-up phase and undergo cytological evaluation annually for 3 y ears. In this follow up phase, colposcopy, biopsy/ECC will be performed only in women with cervical cytology considered 'not normal' at any of the annual follow up visits.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Human Papilloma Virus (HPV)
Device: Cobas® 4800 HPV Test
Experimental: A
Intervention: Device: Cobas® 4800 HPV Test

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47208
June 2013
June 2013   (final data collection date for primary outcome measure)

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 ECC 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
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00709891
RD000649, MWP_HPV_159
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Catherine Behrens Roche Molecular Systems, Inc
Hoffmann-La Roche
June 2010

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