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

NCT00973362 | Completed Phase 3 Results

• 1 other identifier: 2007HPVASCUS30
• Study Type: interventional
• Target: 12,896
• Locations: 1 country
• Sites: 17

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.

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

Outcome Measures

Primary Outcomes (2)

• 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+

  Baseline Evaluation

• 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+

  Baseline Evaluation

Secondary Outcomes (2)

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

  Baseline Evaluation

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

  Baseline Evaluation

Study Arms (2)

Adjunct (i.e. Normal Pap)

OTHER

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.

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

ASC-US

OTHER

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.

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

Interventions

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).

ASC-US; Adjunct (i.e. Normal Pap)

FDA-Approved HPV DNA Test DEVICE

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

ASC-US; Adjunct (i.e. Normal Pap)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gen-Probe, Incorporated: lead

Study Sites (17)

NEA Clinic Women's Clinic

Jonesboro, Arkansas, 72401, United States

Location

San Fernando Valley Research

Canoga Park, California, 91306, United States

Location

Healthcare Partners of Monterey Park

Los Angeles, California, 90015, United States

Location

Diverse Research Solutions

Oxnard, California, 93030, United States

Location

REMEK

Pomona, California, 91767, United States

Location

West Coast OB-Gyn

San Diego, California, 92123, United States

Location

HealthCare Partners

Torrance, California, 90503, United States

Location

Penninsula Research Associates

Torrance, California, 90505, United States

Location

Community Medical Research of South Florida

Miami, Florida, 33141, United States

Location

Insignia Clinical Research

Tampa, Florida, 33613, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences

Indianapolis, Indiana, 46202, United States

Location

Saginaw Valley Medical Research

Saginaw, Michigan, 48604, United States

Location

PPS Clinical

Chesterfield, Missouri, 63017, United States

Location

Planned Parenthood of Eastern Arkansas and Oklahoma

Tulsa, Oklahoma, 74105, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Adams Patterson OB-GYN

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Precancerous Conditions; Morphological and Microscopic Findings

Results Point of Contact

• Title: Vice President Clinical Affairs
• Organization: Hologic, Inc.

rainer.ziermann@hologic.com

858-410-8000

Study Officials

• Jennifer L Reid, PhD

  Gen-Probe, Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 9, 2009
• Study Start: March 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 6, 2017
• Results First Posted: January 6, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)