Clinical validation of UroCAD test for upper tract urothelial carcinoma detection: results from a prospective multi-center study.

ABSTRACT:

Background

Upper tract urothelial carcinoma (UTUC) poses diagnostic challenges due to its anatomical complexity and limited accessibility.

Methods

This prospective multicenter study (NCT05043662) evaluated the diagnostic performance of UroCAD, a novel non-invasive assay based on chromosomal copy number variation (CNV) analysis, in 244 patients with suspected UTUC or benign upper urinary tract conditions.

Results

Urine samples were analyzed for arm-level chromosomal aberrations (|Z-score|≥ 3.21), with histopathology as the reference standard. UroCAD demonstrated excellent diagnostic accuracy: sensitivity 91.0%, specificity 97.0%, and overall accuracy 93.4%. Performance was consistent across tumor locations (renal pelvis: 96.8%, ureter: 86.4%) and grades (high-grade: 93

SUBMITTER: Yang G 

PROVIDER: S-EPMC12784582 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature