Ultrasound-Guided Core Needle Biopsy to Stage Urothelial Carcinoma of the Bladder (US UCB)

NCT ID: NCT07029256

Last Updated: 2025-12-30

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-26

Study Completion Date

2030-07-30

Brief Summary

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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).

Detailed Description

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Conditions

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Bladder Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

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

* Undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder
* Prior abdominal imaging

Exclusion Criteria

* History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)
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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Vidit Sharma, 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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Hosanna Yeadon, BA

Role: CONTACT

Phone: 507-538-5019

Email: [email protected]

Clinical Trials Referral Office

Role: CONTACT

Phone: 855-776-0015

Email: [email protected]

Facility Contacts

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Hosanna Yeadon, BA

Role: primary

Clinical Trials Referral Office

Role: backup

Related Links

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Other Identifiers

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NCI-2024-09054

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-008092

Identifier Type: OTHER

Identifier Source: secondary_id

23-008092

Identifier Type: -

Identifier Source: org_study_id