NCT07029256

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
50mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jul 2024Jul 2030

Study Start

First participant enrolled

July 26, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2030

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

6 years

First QC Date

June 10, 2025

Last Update Submit

June 8, 2026

Conditions

Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (after completion of bladder surgery)

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing radical cystectomy for confirmed or suspected urothelial carcinoma of the bladder

You may qualify if:

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

You may not qualify if:

  • History of partial cystectomy or complex bladder reconstruction or substitution (i.e. bladder augment or urothelial recurrence in a neobladder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Bladder tissue

Study Officials

  • Vidit Sharma, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hosanna Yeadon, BA

CONTACT

507-538-5019biffert.hosanna@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 19, 2025

Study Start

July 26, 2024

Primary Completion (Estimated)

July 30, 2030

Study Completion (Estimated)

July 30, 2030

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)