The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

Recruiting

• Conditions: Urothelial Carcinoma
• Interventions: Diagnostic Test: IUrisure test

• 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

Study Timeline

• Study Start: 2023-06-01
• Status Verified: 2023-11
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Last Update Submitted: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. 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;
2. 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;
3. 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

Arm && Interventions

Group	Intervention	Description
Urothelial carcinoma Patients	IUrisure test	Patients with urothelial carcinoma, which can be primary or recurrent, should be eligible for surgery including transurethral resection of bladder tumours (TURbt), partial cystectomy, radical nephroureterectomy, and kidney-sparing surgery. Urine samples were collected before and after surgery. The follow-up period was 24 months, and the patients underwent routine tests during the follow-up period. The gold standard for recurrence of urothelial carcinoma is surgical/biopsy pathology.

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China