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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Human Papillomavirus Infection

Intervention / Treatment
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* Device: APTIMA HPV Assay
* Device: FDA-Approved HPV DNA Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adjunct (i.e. Normal Pap)<br>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<br>* 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).<br>Device: FDA-Approved HPV DNA Test<br>* A FDA-Approved HPV DNA Test is used as the comparator assay.<br>|
| Other: ASC-US<br>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<br>* 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).<br>Device: FDA-Approved HPV DNA Test<br>* A FDA-Approved HPV DNA Test is used as the comparator assay.<br>|

What is the study measuring?
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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+ | 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+ | Baseline Evaluation | 
| Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+ | 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+ | Baseline Evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies) | ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies) | Baseline Evaluation | 
| ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies) | ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay | Baseline Evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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