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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: Completed Phase 3 study of Human Papillomavirus Infection, sponsored by Gen-Probe, Incorporated.
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 693-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (1761% higher). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Adjunct 30+ yrs. Population: Aptima HPV Assay Performance for Detecting CIN2+: Compare Clinical Performance of the Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 12,896 participants |
| Start Date | 2008-03 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT00973362 record still lists
NCT00973362 is an interventional study that assigns participants to a tested intervention. Its 12,896 participants enrollment target places it among the larger protocols in the corpus, above the 693-participant average among 22 other Human Papillomavirus Infection trials with a reported enrollment target (1761% higher).
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 lists 17 locations in 10 states (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.
Learn More About Clinical Trials
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Where NCT00973362's enrollment target sits among peer trials
12,896 1st of 22 higher than 22 of 22 other Human Papillomavirus Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Human Papillomavirus Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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