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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening

Conditions
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Human Papilloma Virus (HPV)

Intervention / Treatment
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* Device: cobas® 4800 HPV Test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cobas® 4800 HPV Test<br>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. | Device: cobas® 4800 HPV Test<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to the end of the Baseline period (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to the end of the study (up to 5 years, 1 month) |