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

N/A

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to the end of the study (up to 5 years, 1 month)

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Human Papillomavirus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of the study (up to 5 years, 1 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the end of the study (up to 5 years, 1 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the study (up to 5 years, 1 month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With a Diagnosis of ≥ CIN2

Secondary study objectives

Percentage of Participants With a Diagnosis of ≥ CIN3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: cobas® 4800 HPV TestExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cobas® 4800 HPV Test

2008

N/A

~47210

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