Status:
COMPLETED
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
Lead Sponsor:
Gen-Probe, Incorporated
Conditions:
Human Papillomavirus Infection
Eligibility:
FEMALE
21+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
12896 Patients enrolled
Trial Details
Trial ID
NCT00973362
Start Date
March 1 2008
End Date
April 1 2014
Last Update
January 6 2017
Active Locations (17)
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1
NEA Clinic Women's Clinic
Jonesboro, Arkansas, United States, 72401
2
San Fernando Valley Research
Canoga Park, California, United States, 91306
3
Healthcare Partners of Monterey Park
Los Angeles, California, United States, 90015
4
Diverse Research Solutions
Oxnard, California, United States, 93030