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

Roche

Status: Completed

Conditions: Human Papilloma Virus (HPV)

Treatments: Device: cobas® 4800 HPV Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709891

MWP-HPV-159 (Other Identifier)

RD000649

Details and patient eligibility

About

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.

Enrollment: 47,208 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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47,208 participants in 1 patient group

cobas® 4800 HPV Test

Experimental group

Description:

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:

Device: cobas® 4800 HPV Test