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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00709891
First received: June 30, 2008
Last updated: February 25, 2013
Last verified: June 2010
History of Changes
  Purpose

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 undergoing 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 cytology 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 years. 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.


Condition Intervention
Human Papilloma Virus (HPV)
 Device: Cobas® 4800 HPV Test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 Using Cervical Samples Prepared With the COBAS X421 Instrument

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45000
Study Start Date: May 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Cobas® 4800 HPV Test

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709891

  Show 61 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Eric Fung Roche Molecular Systems, Inc
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00709891     History of Changes
Other Study ID Numbers: RD000649, MWP_HPV_159
Study First Received: June 30, 2008
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Papilloma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 21, 2013