Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population

This is a prospective, single-center diagnostic clinical study designed to evaluate the performance of a urine-based immunofluorescence cytology test for the detection of urological malignancies in patients presenting with hematuria. The study will enroll 170 eligible participants who are scheduled for cystoscopy and/or ureteroscopy. Urine samples will be collected prior to endoscopy and subjected to both the index immunofluorescence assay and DNA ploidy analysis, with the results compared against the reference standard of endoscopic biopsy and histopathology. The primary objective is to estimate the sensitivity, specificity, and negative predictive value of the immunofluorescence test. Secondary objectives include evaluating the diagnostic accuracy of DNA ploidy analysis, comparing the two index tests using paired statistical methods (e.g., McNemar's test), and assessing their agreement with the reference standard via Kappa statistics. Sample size calculation, based on an assumed malignancy rate of 15% and a target of at least 23 pathology-confirmed malignant cases, ensures adequate power for the primary comparison. The study will follow standardized operating procedures, with independent, blinded interpretation by trained cytopathologists. Statistical analyses will be performed using R or SPSS, with a two-sided significance level of 0.05. The trial is scheduled to commence in April 2026 and is expected to conclude by June 2027, with the aim of providing evidence for a non-invasive, rapid, and cost-effective screening tool in hematuria populations.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Presenting with hematuria requiring urological malignancy workup

Age ≥ 18 years

Planned to undergo cystoscopy and/or ureteroscopy

Able to provide written informed consent

Exclusion Criteria:

* Prior confirmed diagnosis of urological malignancy

Participation in another clinical trial within 3 months prior to enrollment

Any clinical condition that, per investigator judgment, may interfere with study execution

Inadequate urine sample quality or volume