Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System

Completed · Phase 3

Conditions studied: Human Papillomavirus Infection

In brief

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.

Key facts

Study ID

NCT00973362

Run by

Gen-Probe, Incorporated

People needed

12896

Starts

2008-03-01

Expected to finish

2014-04-01

Last updated by the study team

2017-01-06

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Female 21 years or older (ASC-US study only)
• Female 30 years or older (Adjunct and ASC-US studies)
• Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
• Ability to comprehend and sign an IRB-approved Informed Consent Form

You may not qualify if…

• Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
• Abnormal Pap test result in the past 12 months
• Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
• Known to be pregnant
• Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
• Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
• Prior vaccination for HPV

Where it is running

• 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

Full record on ClinicalTrials.gov

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