Clinical trial NCT00973362: Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus Infection
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
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 12896
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
timeFrame: Baseline Evaluation
measure: Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
timeFrame: Baseline Evaluation
Secondary outcomes:
measure: ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
timeFrame: Baseline Evaluation
measure: ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
timeFrame: Baseline Evaluation
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: NEA Clinic Women's Clinic
state: Arkansas
city: Canoga Park
country: United States
facility: San Fernando Valley Research
state: California
city: Los Angeles
country: United States
facility: Healthcare Partners of Monterey Park
state: California
city: Oxnard
country: United States
facility: Diverse Research Solutions
state: California
city: Pomona
country: United States
facility: REMEK
state: California
city: San Diego
country: United States
facility: West Coast OB-Gyn
state: California
city: Torrance
country: United States
facility: HealthCare Partners
state: California
city: Torrance
country: United States
facility: Penninsula Research Associates
state: California
city: Miami
country: United States
facility: Community Medical Research of South Florida
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
state: Indiana
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research
state: Michigan
city: Chesterfield
country: United States
facility: PPS Clinical
state: Missouri
city: Tulsa
country: United States
facility: Planned Parenthood of Eastern Arkansas and Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Adams Patterson OB-GYN
state: Tennessee
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer L Reid, PhD
role: STUDY_DIRECTOR
References: