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

Hoffmann-La Roche47,208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

47,208

Conditions

Human Papilloma Virus (HPV)

Interventions

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (61)

Unnamed facility

Enterprise, Alabama, United States

Unnamed facility

Hoover, Alabama, United States

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Outcomes

Primary Outcomes

Percentage of Participants With a Diagnosis of ≥ CIN2

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.

Time frame: Baseline to the end of the Baseline period (up to 12 weeks)

Secondary Outcomes

Percentage of Participants With a Diagnosis of ≥ CIN3

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.

Time frame: Baseline to the end of the study (up to 5 years, 1 month)