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Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

NCT ID: NCT01446198

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11816 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Detailed Description

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The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Conditions

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Human Papilloma Virus Infection

Keywords

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HPV

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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AHPV positive and negative subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
* an aliquot is available and suitable for testing, and
* the sample was randomly selected for inclusion.

Exclusion Criteria

* sample integrity was compromised (eg, stored under unacceptable conditions)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gen-Probe, Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tadd S Lazarus, M.D.

Role: STUDY_DIRECTOR

Gen-Probe, Incorporated

Locations

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Gen-Probe Incorporated

San Diego, California, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

LabCorp Corporation of America

Burlington, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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AHPVPS-US11-003

Identifier Type: -

Identifier Source: org_study_id