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

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ClinicalTrials.gov Identifier: NCT00973362
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated

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.

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Device: APTIMA HPV Assay Device: FDA-Approved HPV DNA Test Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12896 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 Start Date : March 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : April 2014

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Arm Intervention/treatment
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.
Device: 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).

Device: 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.
Device: 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).

Device: FDA-Approved HPV DNA Test
A FDA-Approved HPV DNA Test is used as the comparator assay.




Primary Outcome Measures :
  1. Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+ [ Time Frame: Baseline Evaluation ]
    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+

  2. 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 ]
    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+


Secondary Outcome Measures :
  1. ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies) [ Time Frame: Baseline Evaluation ]
    ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)

  2. ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies) [ Time Frame: Baseline Evaluation ]
    ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973362


Locations
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Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
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Study Director: Jennifer L Reid, PhD Gen-Probe, Incorporated
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Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT00973362    
Other Study ID Numbers: 2007HPVASCUS30
First Posted: September 9, 2009    Key Record Dates
Results First Posted: January 6, 2017
Last Update Posted: January 6, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gen-Probe, Incorporated:
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:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections