Bladder CarcinomaNCT06109857
Bladder Bank (a Prospective Banking Study)
An observational study of Bladder Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2022to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient has undergone office-based evaluation for hematuria
Who may be able to join
- Age \> 18 years
- Patient has undergone office-based evaluation for hematuria [computed tomography (CT), ultrasound, cystoscopy]
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
John B. Kisiel, MD
About this 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Bladder Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood and urine sample collection and have their medical records reviewed while on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start6 Jul 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John B. Kisiel, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109857
- Sponsor's protocol ID
- 21-009854
- Other IDs
- NCI-2023-00644, 21-009854
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Bank (a Prospective Banking Study)
- ClinicalTrials.gov ID
- NCT06109857
- Acronym / sponsor ID
- 21-009854
- Conditions
- Bladder Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood and urine sample collection and have their medical records reviewed while on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient has undergone office-based evaluation for hematuria
Key inclusion criteria (2 listed)
- Age \> 18 years
- Patient has undergone office-based evaluation for hematuria [computed tomography (CT), ultrasound, cystoscopy]
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Bladder Carcinoma
Active, not recruitingEarly Phase 1
(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer
Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Active, not recruitingPhase 3
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Advanced Bladder Urothelial Carcinoma, Advanced Renal Pelvis Urothelial Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John B. Kisiel, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sample to support the development of non-invasive tests for early detection of bladder cancer (time frame: Baseline (at enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.