Urothelial Carcinoma
Conditions
Interventions
Gold Standard:Endoscopy (ureteroscopy/cystoscopy) combined with biopsy is the gold standard for the diagnosis of urothelial tumors.
Index test:Multigene Methylation Detection Kit for Urothelial Carcinoma (PCR-Fluorescent Probe Method) .
Sponsors
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Specimen information shall be traceable in full detail, including at minimum traceable identification number, gender, age and relevant clinical background data. 2. No restriction on subject gender; age = 18 years old. 3. The volume of each urine specimen shall not be less than 40 mL. 4. Subjects meeting any one of the following criteria are eligible for enrollment: (1) Patients with clinical manifestations such as hematuria or bladder irritation symptoms, or suspected urothelial carcinoma indicated by abnormal findings on non-invasive imaging examinations requiring further clinical confirmation; and cases where non-invasive imaging fails to determine the necessity of cystoscopic examination. (2) Patients with pathologically confirmed urothelial carcinoma who have not received radiotherapy or chemotherapy prior to enrollment. (3) Patients clinically diagnosed with benign urinary system diseases. (4) Patients diagnosed with other malignant urinary tract tumors excluding urothelial carcinoma. (5) Patients diagnosed with malignant tumors originating from non-urinary organs. (6) A subset of enrolled subjects shall provide paired pre-operative and post-operative specimens from the same individual.
Exclusion criteria
Exclusion criteria: 1. The number of subject specimens fails to meet the required quantity for trial completion. 2. Specimens are collected, processed or stored in non-compliance with specified requirements. 3. Incomplete specimen-related information. 4. Other circumstances deemed inappropriate for trial enrollment by the investigator(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Concordance Rate; | — |
Countries
China
Contacts
Public ContactHuadong He
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Outcome results
None listed