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Recruiting NCT06109857

Bladder Bank (a Prospective Banking Study)

Observational Bladder Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Bladder Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Blood sample to support the development of non-invasive tests for early detection of bladder cancer [Time frame: Baseline (at enrollment)]
  • Urine sample to support the development of non-invasive tests for early detection of bladder cancer [Time frame: Baseline (at enrollment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06109857 · 21-009854 · NCI-2023-00644 · 21-009854

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗