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Completed

NCT Number: NCT00973362

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

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.

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Key information

Conditions

Human Papillomavirus Infection Atypical Squamous Cells of the Cervix Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Morphological and Microscopic Findings Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

NEA Clinic Women's Clinic, Jonesboro, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APTIMA HPV Assay

Device

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).

FDA-Approved HPV DNA Test

Device

A FDA-Approved HPV DNA Test is used as the comparator assay.

Primary outcomes

  1. Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+

    Time frame: 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+

  2. Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+

    Time frame: 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+

Secondary outcomes

  1. ASC-US Study Arm: Aptima HPV Assay Performance for Detecting CIN2+ (All Biopsies)

    Time frame: Baseline Evaluation

    ASC-US Study Arm: 21+ yrs. Population: Aptima HPV assay performance on Tigris System for detecting CIN2+ (All Biopsies)

  2. ASC-US Study Arm: FDA-Approved HPV DNA Assay Performance for Detecting CIN2+ (All Biopsies)

    Time frame: Baseline Evaluation

    ASC_US Study Arm: 21+ yrs. Population for Detecting CIN2+ (All Biopsies): FDA-Approved HPV DNA Assay

Sponsors and collaborators

Lead sponsor

Gen-Probe, Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Sep 9, 2009
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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