Bladder Urothelial CarcinomaNCT07029256
Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder (US UCB)
An observational study of Bladder Urothelial Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2024to 30 Jul 2030
- 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: Patients undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
Who may be able to join
- Undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
- Prior abdominal imaging
Who cannot join
- History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)
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
Hosanna Yeadon, BA, 507-538-5019, biffert.hosanna@mayo.edu
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
About this study
Official title: Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder
This study is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
- Conditions
- Bladder Urothelial Carcinoma
- Being tested
- Non-Interventional Study
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 standard of care radical cystectomy and residual tissues collected undergo US core needle biopsy. Additionally, patients have their medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between US and core needle biopsy stage and final surgical specimen pathologic stage
The radiology-assessed tumor stage from the ultrasound (US) and the core needle biopsy-assessed tumor stage will be compared with the final pathologic tumor stage.
Measured: Baseline (after completion of bladder surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start26 Jul 2024
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vidit Sharma, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029256
- Sponsor's protocol ID
- 23-008092
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT07029256
- Acronym / sponsor ID
- 23-008092
- Conditions
- Bladder Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 19 Jun 2025 (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 is being done to test the feasibility and accuracy of using an ultrasound-guided core needle biopsy technique as a potential tool for staging urothelial carcinoma of the bladder (UCB).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo standard of care radical cystectomy and residual tissues collected undergo US core needle biopsy. Additionally, patients have their medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
Key inclusion criteria (2 listed)
- Undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
- Prior abdominal imaging
Key exclusion criteria (1 listed)
- History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)
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
Concordance between US and core needle biopsy stage and final surgical specimen pathologic stage
Time frame: Baseline (after completion of bladder surgery)
The radiology-assessed tumor stage from the ultrasound (US) and the core needle biopsy-assessed tumor stage will be compared with the final pathologic tumor stage.
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 10 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vidit Sharma, 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 Urothelial 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 1 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 10 Jun 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 Hosanna Yeadon, BA (507-538-5019, biffert.hosanna@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between US and core needle biopsy stage and final surgical specimen pathologic stage (time frame: Baseline (after completion of bladder surgery)). 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 10 Jun 2026.