Bladder Bank (a Prospective Banking Study)

Recruiting

• Conditions: Bladder Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06109857
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-07-06
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 muscle invasive bladder cancer
• Patient has ever been previously diagnosed with UTUC (upper tract urothelial carcinoma) prior to bladder resection
• Patient has received chemotherapy class drugs for the treatment of non-target origin 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo blood and urine sample collection and have their medical records reviewed while on study.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States