Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection

Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.

Condition or diseaseIntervention/treatment
Upper Tract Urothelial CarcinomaOther: Active Comparator: Surgery Pathology or CystoscopyOther: Active Comparator: Clinical Diagnosis

Detailed Description:

This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.