Bladder Bank (a Prospective Banking Study)

NCT06109857 | Recruiting

• 2 other identifiers: 21-009854NCI-2023-00644
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Observational

Patients undergo blood and urine sample collection and have their medical records reviewed while on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient has undergone office-based evaluation for hematuria

You may qualify if:

• Age \> 18 years
• Patient has undergone office-based evaluation for hematuria \[computed tomography (CT), ultrasound, cystoscopy\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Collection: At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and will be processed according to standardized study biospecimen protocol. Specimens will be stored in a secure lab for future approved research. Urine Collection: At study enrollment for subjects, up to 20mL of urine in 5 ml aliquots (stored with or without fixative in up to 5 equal aliquots) from the same or unique case patients above targeted for blood collection.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• John B. Kisiel, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: July 6, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)