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

Upper Tract Urothelial Carcinoma Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04948528
Study type Observational
Source AnchorDx Medical Co., Ltd.
Contact Xu Chen, MD
Phone +86-13430306339
Email chenx457@mail.sysu.edu.cn
Status Recruiting
Phase
Start date September 1, 2020
Completion date December 31, 2023
View Details
See also
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