Bladder Bank (a Prospective Banking Study)

Study Overview
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Brief Summary
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This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.

Detailed Description
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PRIMARY OBJECTIVE: I. To establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer. OUTLINE: This is an observational study. Patients undergo blood and urine sample collection and have their medical records reviewed while on study.

Official Title
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Bladder Bank (a Prospective Banking Study)

Conditions
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Bladder Carcinoma, Hematuria

Intervention / Treatment
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* Other: Non-Interventional Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Patient has undergone office-based evaluation for hematuria (computed tomography [CT], ultrasound, cystoscopy) Exclusion Criteria: Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible) Patient has recurrent bladder cancer Patient has ever been previously diagnosed with UTUC (upper tract urothelial carcinoma) prior to bladder resection Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection Patient has had any prior radiation therapy to the target lesion prior to current collection Patient has had a biopsy to the target organ and/or lesion within 3 days before collection Patient has undergone cystectomy Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection Patient has had a urinary tract infection within 14 days prior to urine collection Patient has chronic indwelling urinary catheter Patient has prior diagnosis of bladder cancer for which prior resection of tumor was performed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients undergo blood and urine sample collection and have their medical records reviewed while on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sample to support the development of non-invasive tests for early detection of bladder cancer | At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and processed according to standardized study biospecimen protocol. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic. | Baseline (at enrollment) | 
| Urine sample to support the development of non-invasive tests for early detection of bladder cancer | At study enrollment for subjects, up to 20mL of urine will be collected from the same or unique case patients identified for blood collection. All samples will be stored for future analysis in Molecular Cancer Diagnostic Laboratory at Mayo Clinic. | Baseline (at enrollment) |