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NCT01024959 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
A NA study, sponsored by Gen-Probe, Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 507
- Enrollment target
NCT01024959 is a NA study that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 507 participants.
The verdict
NCT01024959, a NA study, has completed, sponsored by Gen-Probe, Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 507 participants
- Enrollment target
Study Summary
The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.
Interventions
- OTHER PCA3 Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01024959
The ClinicalTrials.gov registry entry for NCT01024959 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 507 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gen-Probe, Incorporated, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PCA3 Assay is the first listed.
NCT01024959 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01024959 about?
NCT01024959 is a clinical study titled "Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result". The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased ...
What is the current status of trial NCT01024959?
This trial is currently completed. It is a NA study. The enrollment target is 507 participants. The study started on 2009-08. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01024959?
The interventions under investigation include: PCA3 Assay (OTHER).
Who is sponsoring clinical trial NCT01024959?
This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
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