Status:
UNKNOWN
The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma
Lead Sponsor:
Wuhan Ammunition Life-tech Co., Ltd
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
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 rec...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06564363
Start Date
June 1 2023
End Date
December 31 2025
Last Update
August 21 2024
Active Locations (1)
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1
Peking University First Hospital
Beijing, China