Trial Information

Summary: A Study Evaluating the Performance of the AMPLICOR HPV Test and LINEAR ARRAY High Risk HPV Genotyping Test (LA HPV Test) in Identifying High-Grade Cervical Disease Women Undergoing Routine Cervical Cancer.

Status: Recruiting

Protocol Number: RD000649

Sponsor:

Company Division: Diagnostic

Official Scientific Title:

Evaluation of the AMPLICOR HPV test and the LINEAR ARRAy High Risk HPV genotyping test for the detection of high-grade cervical disease in women undergoing routine cervical cancer screening using cervical samples prepared with the X421 instrument.

Brief Summary:

This study will provide data on the performance of the AMPLICOR HPV test and the LA HPV test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase will be conducted with approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 will be selected to undergo colposcopy and biopsy/ECC at baseline. These subjects will include women with cytology that is 'not normal' and a selection of those with 'normal' cytology who will enter a follow-up phase and undergo cytological evaluation annually for 3 years. In this follow up phase, colposcopy, biopsy/ECC will be performed only in women with cervical cytology considered 'not normal' at any of the annual follow up visits.

Study Phase: N/A

Study Design / Study Details:

• Purpose:
• Allocation: Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Parallel
• Endpoints:

Study Type:

Condition: Human Papilloma Virus (HPV)

Intervention Type: Diagnostic Test

Intervention Name: Amplicor HPV Test

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: Yes

Anticipated Start Date: May, 2008

Trial Registration Date: 07/09/2008

Date Last Updated: 07/11/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:17:55 PM