Evaluating the IUrisure test for detecting bladder cancer recurrence
The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma: a Single Center Prospective Study
This study is testing a new urine test called IUrisure to see if it can reliably detect bladder cancer recurrence in patients who are at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wuhan Ammunition Life-tech Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06564363 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of the IUrisure test in detecting recurrent urothelial carcinoma by comparing its sensitivity and specificity to the traditional gold standard of cystoscopy and pathology. Patients with a high suspicion or confirmed diagnosis of urothelial carcinoma will be monitored for recurrence and will undergo the IUrisure test as part of their evaluation. The study seeks to determine whether this new test can provide reliable results that could potentially improve patient management.
Who should consider this trial
Good fit: Ideal candidates include patients with high suspicion or confirmed urothelial carcinoma who are eligible for surgical intervention.
Not a fit: Patients with other malignant tumors or those with low-grade urothelial carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive and more accurate method for monitoring bladder cancer recurrence.
How similar studies have performed: While the IUrisure test is a novel approach, similar studies evaluating non-invasive tests for cancer recurrence have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking University First Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xuesong Li
- Email: pineneedle@sina.com
- Phone: 15801399116
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.