CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12,896 enrolled
Drug / intervention
APTIMA HPV Assay +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00973362
NCT00973362Phase 3Completed
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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

Gen-Probe, Incorporated·interventional·Posted Sep 9, 2009·Updated Jan 6, 2017

In Brief

A Phase 3 clinical trial evaluating APTIMA HPV Assay and FDA-Approved HPV DNA Test for Human Papillomavirus Infection. Completed, enrolled 12,896 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Papillomavirus Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2009
Enrollment StartMar 1, 2008
Primary CompletionJun 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.8 years ago

Interventions

APTIMA HPV Assaydevice

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 Testdevice

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