Spots Global Cancer Trial Database for Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
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Trial Identification
Brief Title: Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Official Title: Clinical Evaluation of the APTIMA® HPV Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
Study ID: NCT00973362
Conditions
Study Description
Brief Summary: The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.
Detailed Description: The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
NEA Clinic Women's Clinic, Jonesboro, Arkansas, United States
San Fernando Valley Research, Canoga Park, California, United States
Healthcare Partners of Monterey Park, Los Angeles, California, United States
Diverse Research Solutions, Oxnard, California, United States
REMEK, Pomona, California, United States
West Coast OB-Gyn, San Diego, California, United States
HealthCare Partners, Torrance, California, United States
Penninsula Research Associates, Torrance, California, United States
Community Medical Research of South Florida, Miami, Florida, United States
Insignia Clinical Research, Tampa, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences, Indianapolis, Indiana, United States
Saginaw Valley Medical Research, Saginaw, Michigan, United States
PPS Clinical, Chesterfield, Missouri, United States
Planned Parenthood of Eastern Arkansas and Oklahoma, Tulsa, Oklahoma, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Adams Patterson OB-GYN, Memphis, Tennessee, United States
Contact Details
Name: Jennifer L Reid, PhD
Affiliation: Gen-Probe, Incorporated
Role: STUDY_DIRECTOR
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