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

Phase 3

Completed

Conditions: Human Papillomavirus Infection

Interventions: Device: APTIMA HPV Assay
Device: FDA-Approved HPV DNA Test

Registration Number: NCT00973362

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 12896

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjunct (i.e. Normal Pap)	FDA-Approved HPV DNA Test	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.
Adjunct (i.e. Normal Pap)	APTIMA HPV Assay	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.
ASC-US	APTIMA HPV Assay	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.
ASC-US	FDA-Approved HPV DNA Test	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.

Primary Outcome Measures

Name	Time	Method
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+	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+
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+	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+

Secondary Outcome Measures

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

Trial Locations

Locations (17): Adams Patterson OB-GYN
🇺🇸
Memphis, Tennessee, United States
Healthcare Partners of Monterey Park
🇺🇸
Los Angeles, California, United States
Community Medical Research of South Florida
🇺🇸
Miami, Florida, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
PPS Clinical
🇺🇸
Chesterfield, Missouri, United States
San Fernando Valley Research
🇺🇸
Canoga Park, California, United States
NEA Clinic Women's Clinic
🇺🇸
Jonesboro, Arkansas, United States
Diverse Research Solutions
🇺🇸
Oxnard, 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
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
Planned Parenthood of Eastern Arkansas and Oklahoma
🇺🇸
Tulsa, Oklahoma, United States
REMEK
🇺🇸
Pomona, California, United States