NCT04314245

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,170 (actual)
• Sponsor: AnchorDx Medical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Urothelial Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
OTHER	Active Comparator: Pathology	Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
OTHER	Active Comparator: Clinical Diagnosis	Routine clinical diagnosis and treatment of benign disease of the urinary system
OTHER	Active Comparator: Clinical diagnosis	Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
OTHER	Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay	A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-11-30
• Completion: 2022-08-31
• First posted: 2020-03-19
• Last updated: 2023-05-24

Locations

1 site across 1 country: China