Bladder Bank (a Prospective Banking Study)

NCT ID: NCT06109857

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-06

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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Bladder Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John B. Kisiel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2023-00644

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-009854

Identifier Type: OTHER

Identifier Source: secondary_id

21-009854

Identifier Type: -

Identifier Source: org_study_id

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