Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

June 7, 2011 updated by: Predictive Biosciences

Phase 3 Study of Bladder Cancer Recurrence Surveillance

The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • BCG Oncology
    • Colorado
      • Engelwood, Colorado, United States, 80113
        • Urology Associates
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Orlando, Florida, United States, 32803
        • Winter Park Urology
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Validation Support Services
      • Woodbury, Minnesota, United States, 55125
        • Metro Urology
    • New Jersey
      • 741 Northfield Avenue, New Jersey, United States, 07052
        • Associates in Urology/Urology Group of NJ
      • Brick, New Jersey, United States, 08723
        • Coastal Urology Associates
    • New York
      • Albany, New York, United States, 12208
        • Community Care Physicians
      • Albany, New York, United States, 12208
        • Capital Regional Urological Surgeons
      • New York, New York, United States, 10016
        • University Urology Associates
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Urological Associates of Lancaster
      • Pittsburgh, Pennsylvania, United States, 15212
        • Triangle Urologic Group
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be from urology and oncology practices

Description

Inclusion Criteria:

  • Intact bladder
  • Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening
  • Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR
  • Must be willing to sign IRB approved informed consent

Exclusion Criteria:

  • History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer
  • Known diagnosis of any autoimmune disease or HIV, HCV or HBV
  • History or current TB or any other active infection
  • Subject has gross hematuria
  • Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment
  • Any surgery except urologic within past 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Predictive Biosciences

Investigators

  • Study Director: Ellen Sheets, MD, Predictive Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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