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The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

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 details
    Urothelial Carcinoma

NCT06564363

Wuhan Ammunition Life-tech Co., Ltd

15 October 2025

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