The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma: a Single Center Prospective Study

Wuhan Ammunition Life-tech Co., Ltd1 site in 1 country148 target enrollmentJune 1, 2023

ConditionsUrothelial Carcinoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Urothelial Carcinoma
Sponsor: Wuhan Ammunition Life-tech Co., Ltd
Enrollment: 148
Locations: 1
Primary Endpoint: Specificity of IUrisure test
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.

Registry

clinicaltrials.gov

Start Date

June 1, 2023

End Date

December 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Wuhan Ammunition Life-tech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with high suspicion/confirmed urothelial carcinoma by CT, CTU, MR and other imaging examinations and meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
•Patients with highly suspected/confirmed recurrence of urothelial carcinoma who meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
•The patient agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria

•(1) Patients with urothelial carcinoma combined with other malignant tumors; (2) Patients with a history of other non-urothelial carcinoma cancers; (3) Samples that are not urothelial carcinoma in surgical pathology; (4) Samples of Ta/low-grade urothelial carcinoma shown by surgical pathology.