Bladder Bank (a Prospective Banking Study) | NCT06109857

Studies
Bladder Bank (a Prospective Banking Study)

NCT06109857

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Bladder Carcinoma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2023-00644	Registry Identifier	CTRP (Clinical Trial Reporting Program)
21-009854	Other Identifier	Mayo Clinic in Rochester

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2022Actual

Primary Completion Date

Dec 1, 2027Estimated

Completion Date

Dec 1, 2027Estimated

First Submitted Date

Oct 25, 2023

First Submission Date that Met QC Criteria

Oct 25, 2023

First Posted Date

Oct 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients undergo blood and urine sample collection and have their medical records reviewed while on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age &gt; 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient has undergone office-based evaluation for hematuria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Referral Office	Contact	855-776-0015		mayocliniccancerstudies@mayo.edu

Overall Officials

Name	Affiliation	Role
John B. Kisiel, MD	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

ID	Term
D001749	Urinary Bladder Neoplasms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Description

Blood Collection: At study enrollment for subjects, 60 ml (4 tablespoons) of blood will be drawn from all participants and will be processed according to standardized study biospecimen protocol. Specimens will be stored in a secure lab for future approved research.

Urine Collection: At study enrollment for subjects, up to 20mL of urine in 5 ml aliquots (stored with or without fixative in up to 5 equal aliquots) from the same or unique case patients above targeted for blood collection.