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

Not Applicable

Completed

• Conditions: Human Papilloma Virus (HPV)
• Interventions: Device: cobas® 4800 HPV Test

• Registration Number: NCT00709891
• Lead Sponsor: Hoffmann-La Roche

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-01-20
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-05
• Last Update Submitted: 2015-02-05
• Results First Posted: 2015-02-09
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47208

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cobas® 4800 HPV Test	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Diagnosis of ≥ CIN2	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Diagnosis of ≥ CIN3	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.