Evaluation of the APTIMA® HPV Assay on the TIGRIS System in ASC-US and Negative for Intraepithelial Lesion/Malignancy (NILM) Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT00973362
First received: September 4, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to provide data on the performance of the APTIMA HPV Assay in detecting HPV types that may cause cervical cancer.


Condition Intervention Phase
Human Papillomavirus Infection
Device: APTIMA HPV Assay
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gen-Probe, Incorporated:

Primary Outcome Measures:
  • ASC-US: Performance Characteristics (sensitivity, specificity, PPV, NPV) with 95% Confidence Intervals Adjunct: Relative Risk of CIN2+ in APTIMA HPV+ vs APTIMA HPV- with 95% Confidence Interval [ Time Frame: ASC-US: Baseline; Adjunct: Baseline and after 3-year follow-up ] [ Designated as safety issue: No ]

Enrollment: 12982
Study Start Date: March 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adjunct (i.e. Normal Pap)
The Adjunct study will evaluate APTIMA HPV Assay 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.
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).
ASC-US
The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay 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).
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).

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female of any age (ASC-US study only)
  • Female 30+ yrs of age (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973362

Locations
United States, Arkansas
NEA Clinic Women's Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
San Fernando Valley Research
Canoga Park, California, United States, 91306
Healthcare Partners of Monterey Park
Los Angeles, California, United States, 90015
Diverse Research Solutions
Oxnard, California, United States, 93030
REMEK
Pomona, California, United States, 91767
West Coast OB-Gyn
San Diego, California, United States, 92123
HealthCare Partners
Torrance, California, United States, 90503
Penninsula Research Associates
Torrance, California, United States, 90505
United States, Florida
Community Medical Research of South Florida
Miami, Florida, United States, 33141
Insignia Clinical Research
Tampa, Florida, United States, 33613
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences
Indianapolis, Indiana, United States, 46202
United States, Michigan
Saginaw Valley Medical Research
Saginaw, Michigan, United States, 48604
United States, Missouri
PPS Clinical
Chesterfield, Missouri, United States, 63017
United States, Oklahoma
Planned Parenthood of Eastern Arkansas and Oklahoma
Tulsa, Oklahoma, United States, 74105
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Adams Patterson OB-GYN
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer L Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT00973362     History of Changes
Other Study ID Numbers: 2007HPVASCUS30
Study First Received: September 4, 2009
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gen-Probe, Incorporated:
cervix cancer
cervical intraepithelial neoplasia
HPV
APTIMA
CIN

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014