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

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
APTIMA HPV Assay
FDA-Approved HPV DNA Test
Sponsored by
Gen-Probe, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Human Papillomavirus Infection focused on measuring 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • NEA Clinic Women's Clinic
  • San Fernando Valley Research
  • Healthcare Partners of Monterey Park
  • Diverse Research Solutions
  • REMEK
  • West Coast OB-Gyn
  • HealthCare Partners
  • Penninsula Research Associates
  • Community Medical Research of South Florida
  • Insignia Clinical Research
  • Emory University School of Medicine
  • Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
  • Saginaw Valley Medical Research
  • PPS Clinical
  • Planned Parenthood of Eastern Arkansas and Oklahoma
  • Temple University Hospital
  • Adams Patterson OB-GYN

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Adjunct (i.e. Normal Pap)

ASC-US

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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+
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+

Secondary Outcome Measures

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)
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

Full Information

First Posted
September 4, 2009
Last Updated
November 9, 2016
Sponsor
Gen-Probe, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00973362
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gen-Probe, Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12896 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjunct (i.e. Normal Pap)
Arm Type
Other
Arm Description
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.
Arm Title
ASC-US
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
APTIMA HPV Assay
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
FDA-Approved HPV DNA Test
Intervention Description
A FDA-Approved HPV DNA Test is used as the comparator assay.
Primary Outcome Measure Information:
Title
Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Description
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+
Time Frame
Baseline Evaluation
Title
Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Description
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+
Time Frame
Baseline Evaluation
Secondary Outcome Measure Information:
Title
ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)
Description
ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)
Time Frame
Baseline Evaluation
Title
ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)
Description
ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay
Time Frame
Baseline Evaluation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Reid, PhD
Organizational Affiliation
Gen-Probe, Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
NEA Clinic Women's Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
San Fernando Valley Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91306
Country
United States
Facility Name
Healthcare Partners of Monterey Park
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Diverse Research Solutions
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
REMEK
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
West Coast OB-Gyn
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
HealthCare Partners
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Penninsula Research Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Community Medical Research of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
Insignia Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Saginaw Valley Medical Research
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
PPS Clinical
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Planned Parenthood of Eastern Arkansas and Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Adams Patterson OB-GYN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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