The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma
Recruiting
- Conditions
- Urothelial Carcinoma
- Registration Number
- NCT06564363
- Lead Sponsor
- Wuhan Ammunition Life-tech Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 148
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specificity of IUrisure test Day 1 The proportion of negatives that are correctly identified as such by the gold standard
Sensitivity of IUrisure test Day 1 The proportion of positives that are correctly identified as such by the gold standard
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, China
Peking University First Hospital🇨🇳Beijing, China