Bladder Bank (a Prospective Banking Study)

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

Study Overview

• Status: Recruiting
• Conditions: Bladder Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: John B. Kisiel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient has undergone office-based evaluation for hematuria

Description

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 or cystoprostatectomy
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: John B. Kisiel, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 21-009854 (Other Identifier: Mayo Clinic in Rochester); NCI-2023-00644 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No