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NCT00973362 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Human Papillomavirus Infection, sponsored by Gen-Probe, Incorporated.

Completed
Registry status
Phase 3
Development phase
12,896
Enrollment target
17
Study locations

NCT00973362 is a Phase 3 study of Human Papillomavirus Infection that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 12,896 participants, above the 560-participant average among 17 other Human Papillomavirus Infection trials with a reported enrollment target (2203% higher). The trial reports 17 study locations across 10 states.

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The verdict

NCT00973362, a Phase 3 study of Human Papillomavirus Infection, has completed, sponsored by Gen-Probe, Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
12,896 participants
Enrollment target
17
Study locations

Study 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.

Interventions

  • DEVICE APTIMA HPV Assay
  • DEVICE FDA-Approved HPV DNA Test

Study Locations (17)

California

  • San Fernando Valley Research - Canoga Park
  • Healthcare Partners of Monterey Park - Los Angeles
  • Diverse Research Solutions - Oxnard
  • REMEK - Pomona
  • West Coast OB-Gyn - San Diego
  • HealthCare Partners - Torrance
  • Penninsula Research Associates - Torrance

Florida

  • Community Medical Research of South Florida - Miami
  • Insignia Clinical Research - Tampa

Arkansas

  • NEA Clinic Women's Clinic - Jonesboro

Georgia

  • Emory University School of Medicine - Atlanta

Indiana

  • Indiana Univ. School of Medicine Dept of Pathology Wishard Health Sciences - Indianapolis

Michigan

  • Saginaw Valley Medical Research - Saginaw

Missouri

  • PPS Clinical - Chesterfield

Oklahoma

  • Planned Parenthood of Eastern Arkansas and Oklahoma - Tulsa

Trial Details

FieldValue
Enrollment Target 12,896 participants
Start Date 2008-03
Est. Completion 2014-04
Phase Phase 3

Sponsor

Gen-Probe, Incorporated

12 total trials

What the Registry Record Tells You About NCT00973362

The ClinicalTrials.gov registry entry for NCT00973362 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 12,896 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 560-participant average among 17 other Human Papillomavirus Infection trials with a reported enrollment target (2203% higher). The listed sponsor is Gen-Probe, Incorporated, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Human Papillomavirus Infection appearing as the primary indexed condition, and to 2 interventions - of which APTIMA HPV Assay is the first listed.

NCT00973362 reports 17 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Arkansas.

Frequently Asked Questions

What is clinical trial NCT00973362 about?

NCT00973362 is a clinical study titled "Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System". 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.

What is the current status of trial NCT00973362?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 12,896 participants. The study started on 2008-03. Estimated completion is 2014-04.

What conditions does trial NCT00973362 study?

This clinical trial studies the following conditions: Human Papillomavirus Infection.

What interventions are being tested in trial NCT00973362?

The interventions under investigation include: APTIMA HPV Assay (DEVICE), FDA-Approved HPV DNA Test (DEVICE).

Who is sponsoring clinical trial NCT00973362?

This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00973362 being conducted?

This trial has 17 study locations across Arkansas, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.