NCT00973362

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,896 (actual)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
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).
DEVICE	FDA-Approved HPV DNA Test	A FDA-Approved HPV DNA Test is used as the comparator assay.

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-06-01
• Completion: 2014-04-01
• First posted: 2009-09-09
• Last updated: 2017-01-06
• Results posted: 2017-01-06

Locations

17 sites across 1 country: United States