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Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
Predictive Biosciences
ClinicalTrials.gov Identifier:
NCT00903240
First received: May 14, 2009
Last updated: June 7, 2011
Last verified: November 2009
History of Changes
  Purpose

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


Condition
Bladder Cancer Recurrence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 3 Study of Bladder Cancer Recurrence Surveillance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Predictive Biosciences:

Biospecimen Retention:   Samples With DNA

The specimens to be retained are urine only


Estimated Enrollment: 1000
Study Start Date: May 2009
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be from urology and oncology practices

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903240

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

No publications provided

Responsible Party: Ellen Sheets, Predictive Biosciences
ClinicalTrials.gov Identifier: NCT00903240     History of Changes
Other Study ID Numbers: PBS-001
Study First Received: May 14, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Recurrence
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013