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Therapeutic Areas: Immunology/Infectious Diseases | Nephrology/Urology | Obstetrics/Gynecology
Disease Category: Human Papilloma Virus (HPV)
Trial Information
A Study Evaluating the Performance of the Cobas® 4800 HPV Test in Identifying High-Grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening.
Status: Recruiting
Protocol Number: RD000649
Sponsor:
Company Division: Diagnostic
Official Scientific Title:
Evaluation of the Cobas® 4800 HPV 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 Cobas® 4800 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:
Interventional
Condition: Human Papilloma Virus (HPV)
Intervention Type: Diagnostic Test
Intervention Name: Amplicor HPV Test
Primary Outcome:
Key Secondary Outcomes:
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.
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: 04/29/2009
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Hoover, AL 35216
Phone: 888-662-6728 (U.S. Only)
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