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

CompletedOBSERVATIONAL
Enrollment

1,170

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

November 30, 2021

Study Completion Date

August 31, 2022

Conditions
Urothelial CarcinomaBladder Cancer
Interventions
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.

Trial Locations (1)

510120

Sun Yat-sen Memorial Hospital, Sun Yat-sen University,, Guangzhou

All Listed Sponsors
collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

collaborator

West China Hospital

OTHER

collaborator

RenJi Hospital

OTHER

collaborator

Tongji Hospital

OTHER

collaborator

Peking University People's Hospital

OTHER

collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

collaborator

Southern Medical University, China

OTHER

collaborator

Nanfang Hospital, Southern Medical University

OTHER

collaborator

Sichuan Cancer Hospital and Research Institute

OTHER

collaborator

Affiliated Hospital & Clinical Medical College of Chengdu University

UNKNOWN

lead

AnchorDx Medical Co., Ltd.

INDUSTRY

NCT04314245 - Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma | Biotech Hunter | Biotech Hunter