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

Human Papillomavirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973362
• Other study ID #: 2007HPVASCUS30
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2009
• Last updated: November 14, 2013
• Start date: March 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12982
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

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).

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia
United States	San Fernando Valley Research	Canoga Park	California
United States	PPS Clinical	Chesterfield	Missouri
United States	Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences	Indianapolis	Indiana
United States	NEA Clinic Women's Clinic	Jonesboro	Arkansas
United States	Healthcare Partners of Monterey Park	Los Angeles	California
United States	Adams Patterson OB-GYN	Memphis	Tennessee
United States	Community Medical Research of South Florida	Miami	Florida
United States	Diverse Research Solutions	Oxnard	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	REMEK	Pomona	California
United States	Saginaw Valley Medical Research	Saginaw	Michigan
United States	West Coast OB-Gyn	San Diego	California
United States	Insignia Clinical Research	Tampa	Florida
United States	HealthCare Partners	Torrance	California
United States	Penninsula Research Associates	Torrance	California
United States	Planned Parenthood of Eastern Arkansas and Oklahoma	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		ASC-US: Baseline; Adjunct: Baseline and after 3-year follow-up	No