Bladder Bank (a Prospective Banking Study)

Hematuria Clinical Trial

Official title:

Bladder Bank (a Prospective Banking Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109857
• Other study ID #: 21-009854
• Secondary ID: NCI-2023-0064421
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Carcinoma
• Hematuria
• Urinary Bladder Neoplasms

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)