- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973362
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
November 9, 2016 updated by: Gen-Probe, Incorporated
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12896
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- NEA Clinic Women's Clinic
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California
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Canoga Park, California, United States, 91306
- San Fernando Valley Research
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Los Angeles, California, United States, 90015
- Healthcare Partners of Monterey Park
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Oxnard, California, United States, 93030
- Diverse Research Solutions
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Pomona, California, United States, 91767
- REMEK
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San Diego, California, United States, 92123
- West Coast OB-Gyn
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Torrance, California, United States, 90503
- Healthcare Partners
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Torrance, California, United States, 90505
- Penninsula Research Associates
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Florida
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Miami, Florida, United States, 33141
- Community Medical Research of South Florida
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Tampa, Florida, United States, 33613
- Insignia Clinical Research
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
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Michigan
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Saginaw, Michigan, United States, 48604
- Saginaw Valley Medical Research
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Missouri
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Chesterfield, Missouri, United States, 63017
- PPS Clinical
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Oklahoma
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Tulsa, Oklahoma, United States, 74105
- Planned Parenthood of Eastern Arkansas and Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Tennessee
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Memphis, Tennessee, United States, 38120
- Adams Patterson OB-GYN
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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).
A FDA-Approved HPV DNA Test is used as the comparator assay.
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Other: 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.
|
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).
A FDA-Approved HPV DNA Test is used as the comparator assay.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Time Frame: Baseline Evaluation
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Adjunct 30+ yrs.
Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
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Baseline Evaluation
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Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Time Frame: Baseline Evaluation
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Adjunct Study Arm: 30+ yrs.
Population: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
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Baseline Evaluation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Time Frame: Baseline Evaluation
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ASC-US Study Arm: 21+ yrs.
Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)
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Baseline Evaluation
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ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Time Frame: Baseline Evaluation
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ASC_US Study Arm: 21+ yrs.
Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay
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Baseline Evaluation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jennifer L Reid, PhD, Gen-Probe, Incorporated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
September 4, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2017
Last Update Submitted That Met QC Criteria
November 9, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
- Cervix Cancer
- Cervical Intraepithelial Neoplasia (CIN)
- Human Papillomavirus Virus (HPV)
- APTIMA HPV Assay
- FDA-Approved HPV DNA Test
- TIGRIS DTS (direct tube sampling) System
- Clinical Sensitivity (%)
- Clinical Specificity (%)
- Positive Predictive Value [PPV] (%)
- Negative Predictive Value [NPV] (%)
- Atypical Squamous Cells Undetermined Significance (ASC-US)
- Relative Risk
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007HPVASCUS30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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