Clinical trial to evaluate the performance characteristics(sensitivity and specificity) of AnchorDx's urine DNA methylation/somatic mutation profiling assay for detecting urothelial carcinoma compared to pathology in patients.
This is a prospective study that involves 11 centers in China and 1200 participants. The assay analyzes the DNA methylation/somatic mutation profiles of bladder cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The performance characteristics(sensitivity and specificity) of the assay for detection of urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.
Study Type
OBSERVATIONAL
Enrollment
1,170
Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
Routine clinical diagnosis and treatment of benign disease of the urinary system
Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University,
Guangzhou, Guangdong, China
Diagnostic Performance for the detection of urothelial carcinoma
The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy.
Time frame: 1 Years
Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma
Sensitivity and specificity of urine DNA methylation/somatic mutation profiling assay in different pathological stages and histologic grades of urothelial carcinoma.
Time frame: 1 Years
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A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.