Urothelial carcinoma
Conditions
Interventions
Gold Standard:Pathological biopsy via cystoscopy
Index test:Automated Urine Detection of Urothelial Carcinoma Urinary Exfoliated Cells Based on Coherent Raman Technology
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above. 2. Patients with gross or microscopic haematuria who have not yet been diagnosed with urothelial carcinoma or recurrence thereof. 3. Absence of severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, haematological disorders, or other serious clinical comorbidities; non-pregnant status. 4. Complete clinical records and laboratory test results. 5. Ability to provide a urine sample prior to treatment. 6. Consent to participate in the study and sign a non-objection form. 7. Capable of giving informed consent and understanding the study objectives.
Exclusion criteria
Exclusion criteria: 1. Under 18 years of age. 2. Incomplete clinical documentation or laboratory test results. 3. Pregnant or lactating women. 4. Presence of other serious clinical comorbidities (e.g., active cardiac disease within 6 months prior to enrolment, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and drug-requiring ventricular arrhythmias). 5. Untreated chronic hepatitis B subjects or hepatitis B virus (HBV) carriers with HBV DNA =500 IU/mL (2500 copies/mL) shall not be included in the study. Note: Patients who are inactive hepatitis B surface antigen carriers or have stable active HBV infection following sustained antiviral therapy (HBV DNA < 500 IU/mL [2500 copies/mL]) may be enrolled. HBV DNA testing is only performed in patients who are positive for hepatitis B surface antigen antibodies. 6. History of immunodeficiency (including human immunodeficiency virus [HIV] positivity, other acquired or congenital immunodeficiency disorders) or history of allogeneic stem cell transplantation or organ transplantation. 7. Ineligibility for the study as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity ;Specificity; | — |
Countries
China
Contacts
Public ContactYao Lin
Peking University First Hospital
Outcome results
None listed