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 COBAS X421 Instrument
N/A
21 Years
N/A
21 Years
N/A
Open (Enrolling)
Female
Human Papilloma Virus (HPV)
Female
Human Papilloma Virus (HPV)
Trial Information
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 COBAS X421 Instrument
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
Outcome Measure:
The clinical endpoint of greater than or equal to CIN2 includes histology results of CIN2, CIN3, cervical cancer, or ACIS
Outcome Time Frame:
Study duration
Safety Issue:
No
Principal Investigator
Eric Fung
Investigator Role:
Study Director
Investigator Affiliation:
Roche Molecular Systems, Inc
Authority:
United States: Institutional Review Board
Study ID:
RD000649
NCT ID:
NCT00709891
Start Date:
May 2008
Completion Date:
June 2013
Related Keywords:
- Human Papilloma Virus (HPV)
- Uterine Cervical Neoplasms
- Uterine Cervical Diseases
- Papilloma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Albany, Georgia 31701 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Charlotte, North Carolina | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Las Vegas, Nevada 89109 | |
| Salt Lake City, Utah 84112 | |
| Coeur D'alene, Idaho 83814 |
