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

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: February 5, 2015
Last verified: February 2015

June 30, 2008
February 5, 2015
May 2008
June 2013   (final data collection date for primary outcome measure)
Percentage of Participants With a Diagnosis of ≥ CIN2 [ Time Frame: Baseline to the end of the Baseline period (up to 12 weeks) ] [ Designated as safety issue: No ]
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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Complete list of historical versions of study NCT00709891 on ClinicalTrials.gov Archive Site
Percentage of Participants With a Diagnosis of ≥ CIN3 [ Time Frame: Baseline to the end of the study (up to 5 years, 1 month) ] [ Designated as safety issue: No ]
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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Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

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.

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Interventional
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Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Human Papilloma Virus (HPV)
Device: cobas® 4800 HPV Test
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

*   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 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.
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
February 2015

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