Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06109857

Conditions

Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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

Study ID

NCT06109857

Start date

Jul 6, 2022

Status verified date

Mar, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

John B. Kisiel, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-16.