Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
NCT ID: NCT00973362
Last Updated: 2017-01-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
12896 participants
INTERVENTIONAL
2008-03-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Adjunct (i.e. Normal Pap)
The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period. A comparator FDA-Approved HPV DNA test is reported.
APTIMA HPV Assay
The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
FDA-Approved HPV DNA Test
A FDA-Approved HPV DNA Test is used as the comparator assay.
ASC-US
The ASC-US study will evaluate the APTIMA HPV Assay clinical performance for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results). A comparator FDA-Approved HPV DNA test is reported. There is no follow-up period.
APTIMA HPV Assay
The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
FDA-Approved HPV DNA Test
A FDA-Approved HPV DNA Test is used as the comparator assay.
Interventions
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APTIMA HPV Assay
The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer ("high-risk types"). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).
FDA-Approved HPV DNA Test
A FDA-Approved HPV DNA Test is used as the comparator assay.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
FEMALE
Yes
Sponsors
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Gen-Probe, Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer L Reid, PhD
Role: STUDY_DIRECTOR
Gen-Probe, Incorporated
Locations
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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
Countries
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Other Identifiers
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2007HPVASCUS30
Identifier Type: -
Identifier Source: org_study_id
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