Bladder Bank (a Prospective Banking Study)

Mayo Clinic

Status: Enrolling

Conditions: Bladder Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06109857

NCI-2023-00644 (Registry Identifier)

21-009854 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study