Urothelial Carcinoma
Conditions
Keywords
Bladder cancer, Upper tract urothelial carcinomas, Recurrence, Methylation
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.
Interventions
DIAGNOSTIC_TESTIUrisure test
Postoperative patients are followed up every three months on average, and IUrisure test was performed at each follow-up visit.
Sponsors
Wuhan Ammunition Life-tech Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactXuesong Li
Outcome results
None listed