Bladder Bank (a Prospective Banking Study)
Study Details
Study Description
Brief Summary
This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational Patients undergo blood and urine sample collection and have their medical records reviewed while on study. |
Other: Non-Interventional Study
Non-interventional study
|
Outcome Measures
Primary Outcome Measures
- Blood sample to support the development of non-invasive tests for early detection of bladder cancer [Baseline (at enrollment)]
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.
- Urine sample to support the development of non-invasive tests for early detection of bladder cancer [Baseline (at enrollment)]
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.
Eligibility Criteria
Criteria
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
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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
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Patient has undergone cystectomy
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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
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Patient has chronic indwelling urinary catheter
-
Patient has prior diagnosis of bladder cancer for which prior resection of tumor was performed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: John B. Kisiel, M.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-009854
- NCI-2023-00644
- 21-009854