Non-invasive Urine Test to Detect Urothelial Carcinoma Early Observational Study Using Urine DNA Methylation and Other Genomic Tests

What this Trial Is About

Researchers are conducting a two-stage, single-center observational study to evaluate noninvasive urine tests for detecting urothelial carcinoma UC, including upper tract urothelial carcinoma UTUC and bladder cancer BC. The study involves adult patients with visible or microscopic blood in the urine and imaging evidence of lesions in the renal pelvis, ureter, or bladder who are scheduled for diagnostic cystoscopy or surgical tissue sampling. Histopathological examination serves as the standard for diagnosis. In Stage 1, completed from October 2019 to December 2023, 113 participants underwent four urine-based tests cytology, fluorescence in situ hybridization FISH, DNA methylation, and a 17-gene mutation panel. Stage 2 began in January 2024 and focuses on urine DNA methylation testing alone due to funding constraints, with around 330 participants enrolled so far. Participants are divided into UC and non-UC groups based on histopathology. Participants provide urine samples and undergo histopathological diagnosis within four weeks, allowing researchers to assess the diagnostic accuracy of these urine tests. The primary outcome is the accuracy of the four urine tests in Stage 1, while key secondary outcomes include the accuracy of DNA methylation testing in Stage 2 and comparisons among tests. Additional analyses explore performance by tumor site and in subsets of Stage 2 participants. The study continues until December 2030.

Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis