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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 is a clinical trial that has completed, run by University of California, Irvine. The registered enrollment target is 100 participants.

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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

FieldValue
Enrollment Target 100 participants
Start Date 2007-03
Est. Completion 2008-09

Sponsor

University of California, Irvine

368 total trials

What the Registry Record Tells You About NCT00581516

The ClinicalTrials.gov registry entry for NCT00581516 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00581516 reports 0 study locations.

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.

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

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.