Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06109857

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

John B. Kisiel, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Blood sample to support the development of non-invasive tests for early detection of bladder cancer

    Time frame: 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.

  2. Urine sample to support the development of non-invasive tests for early detection of bladder cancer

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 31, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.