The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma

Wuhan Ammunition Life-tech

Status: Enrolling

Conditions: Urothelial Carcinoma

Treatments: Diagnostic Test: IUrisure test

Study type: Observational

Funder types: Industry

Identifiers

NCT06564363

BDY003

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

148 participants in 1 patient group

Urothelial carcinoma Patients

Description:

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.

Treatment:

Diagnostic Test: IUrisure test