Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

NCT ID: NCT00903240

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Bladder Cancer Recurrence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Predictive Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Predictive Biosciences

Principal Investigators

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Ellen Sheets, MD

Role: STUDY_DIRECTOR

Predictive Biosciences

Locations

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BCG Oncology

Phoenix, Arizona, United States

Site Status

Urology Associates

Engelwood, Colorado, United States

Site Status

Atlantic Urological Associates

Daytona Beach, Florida, United States

Site Status

Winter Park Urology

Orlando, Florida, United States

Site Status

Metropolitan Urology

Jeffersonville, Indiana, United States

Site Status

Mayo Validation Support Services

Rochester, Minnesota, United States

Site Status

Metro Urology

Woodbury, Minnesota, United States

Site Status

Associates in Urology/Urology Group of NJ

741 Northfield Avenue, New Jersey, United States

Site Status

Coastal Urology Associates

Brick, New Jersey, United States

Site Status

Capital Regional Urological Surgeons

Albany, New York, United States

Site Status

Community Care Physicians

Albany, New York, United States

Site Status

University Urology Associates

New York, New York, United States

Site Status

Hudson Valley Urology

Poughkeepsie, New York, United States

Site Status

Associated Medical Professionals

Syracuse, New York, United States

Site Status

The Urology Group

Cincinnati, Ohio, United States

Site Status

Urological Associates of Lancaster

Lancaster, Pennsylvania, United States

Site Status

Triangle Urologic Group

Pittsburgh, Pennsylvania, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Urology Clinics of North Texas

Dallas, Texas, United States

Site Status

Urology San Antonio Research

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PBS-001

Identifier Type: -

Identifier Source: org_study_id

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