Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

Phase 3 Study of Bladder Cancer Recurrence Surveillance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00903240

Enrollment

1000

Registered

2009-05-18

Start date

2009-05-31

Completion date

2010-10-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer Recurrence

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results