Clinical trial NCT00903240: Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer
Official title: Phase 3 Study of Bladder Cancer Recurrence Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer Recurrence
Lead sponsor: Predictive Biosciences
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be from urology and oncology practices

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


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: BCG Oncology
state: Arizona
city: Engelwood
country: United States
facility: Urology Associates
state: Colorado
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology
state: Florida
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Rochester
country: United States
facility: Mayo Validation Support Services
state: Minnesota
city: Woodbury
country: United States
facility: Metro Urology
state: Minnesota
city: 741 Northfield Avenue
country: United States
facility: Associates in Urology/Urology Group of NJ
state: New Jersey
city: Brick
country: United States
facility: Coastal Urology Associates
state: New Jersey
city: Albany
country: United States
facility: Capital Regional Urological Surgeons
state: New York
city: Albany
country: United States
facility: Community Care Physicians
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals
state: New York
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Triangle Urologic Group
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinics of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
Study officials:
affiliation: Predictive Biosciences
name: Ellen Sheets, MD
role: STUDY_DIRECTOR
References: