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

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, July 2008

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00709891

Purpose

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 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.

Condition	Intervention
HPV	Device: Amplicor HPV Test Device: LINEAR ARRAY High Risk HPV Genotyping Test

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment
Official 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 COBAS X421 Instrument.

Further study details as provided by Hoffmann-La Roche:

Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: Experimental	Device: Amplicor HPV Test Device: LINEAR ARRAY High Risk HPV Genotyping Test

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 ECC 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709891

Contacts

Contact: Please reference Study ID Number: RD000649	+1-973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 27 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials )
Study ID Numbers:	RD000649, MWP_HPV_159
Study First Received:	June 30, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00709891
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 14, 2009