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NCT00581516 · ClinicalTrials.gov registry record
Molecular Urine Tests for Prostate Cancer
A clinical trial, sponsored by University of California, Irvine.
- Completed
- Registry status
- 100
- Enrollment target
NCT00581516: Completed study, sponsored by University of California, Irvine.
NCT00581516 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581516 has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value of PSA it has substantial limitations. To overcome the limitations of total PSA testing, there is emerging evidence demonstrating that relevant cancer biomarker can be detected in urine. Patients who present to the urology clinic for a radical prostatectomy will be asked to enter this study. After obtaining informed consent, the following exam and specimen collection scheduled will be followed: Visit 1 (pre-op): Digital Rectal Exam (DRE) - Voided urine collection \& serum collection Visit 2 (time of prostatectomy): Under anesthesia- catheterized urine collection and serum collection Visit 3 (approximately 8 days post-prostatectomy): Catheterized urine collection Visit 4 (approximately 3 months post-prostatectomy): Voided urine collection and serum collection Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be notified as to whether or not their blood will be drawn during the visits. Pre-operative Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in this patient population with localized prostate cancer. The catheter will be inserted during the time of surgery preparation in the operating room and removed during the post operative clinic appointment.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-09 |
What the finished NCT00581516 record still lists
NCT00581516 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00581516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581516 about?
NCT00581516 is a clinical study titled "Molecular Urine Tests for Prostate Cancer". Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of se...
What is the current status of trial NCT00581516?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2007-03. Estimated completion is 2008-09.
Who is sponsoring clinical trial NCT00581516?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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