Bladder urothelial carcinoma in patients presenting with hematuria Cancer
Conditions
Interventions
This prospective observational diagnostic accuracy study consecutively enrolls adult patients presenting with recurrent hematuria. Participants provide a midstream first morning urine sample (30–50 ml
Sponsors
The Second Affiliated Hospital of Jiaxing University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Recurrent hematuria, including either: 2.1. Intermittent, painless, gross hematuria after renal causes have been ruled out by nephrology consultation; or 2.2. Persistent microscopic hematuria for >6 months confirmed by urinalysis, following exclusion of urinary tract infection 3. Able to provide a midstream first-morning urine sample (30–50 mL) for UroCAD testing 4. Willing and able to undergo cystoscopy and histopathological examination (or surgical resection for pathological confirmation) as the reference standard 5. Provide written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Unwillingness to provide a urine sample 2. Refusal to participate or inability to provide informed consent 3. Prior history of other non-urothelial malignancies 4. Incomplete clinical records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of UroCAD alone and in combination with ultrasonography: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), overall accuracy, and area under the receiver operating characteristic curve (AUC) measured using histopathological examination of bladder tissue obtained via cystoscopy or surgical resection as the reference standard, at a single timepoint at enrollment (cross-sectional assessment; no follow-up required for primary outcome) | — |
Countries
China
Contacts
Public ContactChenye Tang
Outcome results
None listed