Spots Global Cancer Trial Database for Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
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Trial Identification
Brief Title: Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease
Official Title: Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease in Women Undergoing Routine Cervical Cancer Screening
Study ID: NCT00709891
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
, Enterprise, Alabama, United States
, Hoover, Alabama, United States
, Mobile, Alabama, United States
, Phoenix, Arizona, United States
, Phoenix, Arizona, United States
, Tucson, Arizona, United States
, Tucson, Arizona, United States
, Beverly Hills, California, United States
, Carmichael, California, United States
, Costa Mesa, California, United States
, Fountain Valley, California, United States
, San Diego, California, United States
, Colorado Springs, Colorado, United States
, Lakewood, Colorado, United States
, Boynton Beach, Florida, United States
, Ft. Lauderdale, Florida, United States
, Jacksonville, Florida, United States
, Jacksonville, Florida, United States
, Jupiter, Florida, United States
, Lake Worth, Florida, United States
, Miami, Florida, United States
, North Miami, Florida, United States
, Sarasota, Florida, United States
, Tampa, Florida, United States
, West Palm Beach, Florida, United States
, West Palm Beach, Florida, United States
, Atlanta, Georgia, United States
, Decatur, Georgia, United States
, Roswell, Georgia, United States
, Boise, Idaho, United States
, Champaign, Illinois, United States
, Indianapolis, Indiana, United States
, Newburgh, Indiana, United States
, Louisville, Kentucky, United States
, Paducah, Kentucky, United States
, Covington, Louisiana, United States
, Ruston, Louisiana, United States
, Saginaw, Michigan, United States
, Las Vegas, Nevada, United States
, Lawrenceville, New Jersey, United States
, Moorestown, New Jersey, United States
, Albuquerque, New Mexico, United States
, New Bern, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Englewood, Ohio, United States
, Lansdale, Pennsylvania, United States
, West Reading, Pennsylvania, United States
, Columbia, South Carolina, United States
, Hilton Head, South Carolina, United States
, North Charleston, South Carolina, United States
, Chattanooga, Tennessee, United States
, Johnson City, Tennessee, United States
, Nashville, Tennessee, United States
, Corpus Christi, Texas, United States
, Dallas, Texas, United States
, Houston, Texas, United States
, McAllen, Texas, United States
, Temple, Texas, United States
, Salt Lake City, Utah, United States
, Virginia Beach, Virginia, United States
, Tacoma, Washington, United States
Contact Details
Name: Catherine Behrens
Affiliation: Roche Molecular Systems, Inc
Role: STUDY_DIRECTOR
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