Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
NCT04314245 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1170
Last updated 2023-05-24
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.
Conditions
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.
Sponsors & Collaborators
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
collaborator OTHER -
West China Hospital
collaborator OTHER -
RenJi Hospital
collaborator OTHER -
Tongji Hospital
collaborator OTHER -
Peking University People's Hospital
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
The First Affiliated Hospital with Nanjing Medical University
collaborator OTHER -
Southern Medical University, China
collaborator OTHER -
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Sichuan Cancer Hospital and Research Institute
collaborator OTHER -
Affiliated Hospital & Clinical Medical College of Chengdu University
collaborator UNKNOWN -
AnchorDx Medical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jian HUANG, MD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-01
- Primary Completion
- 2021-11-30
- Completion
- 2022-08-31
Countries
- China
Study Locations
More Related Trials
-
PENK Methylation Test for Detecting Bladder Cancer
NCT05220189 ·Status: RECRUITING
-
Identifying Methylation Biomarkers for Monitoring Bladder Tumors
NCT00244205 ·Status: UNKNOWN
-
A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up
NCT04432909 ·Status: UNKNOWN
-
Urine Omics Predicting IO Therapy Responses in mUC Patients
NCT04641936 ·Status: RECRUITING
-
Genomic Imprinting Testing for Diagnosis of Bladder Cancer
NCT03563443 ·Status: UNKNOWN
-
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
NCT05337189 ·Status: RECRUITING
-
Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder
NCT02745301 ·Status: COMPLETED
-
Establishment and Validation of an Early Diagnostic Model for Bladder Cancer Based on Serum and Urine Metabolomics
NCT04966962 ·Status: UNKNOWN
-
Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits
NCT06193941 ·Status: COMPLETED
-
The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients
NCT06245759 ·Status: RECRUITING
-
The Performance of Cancer Risk Genes in the Necessity of Secondary TURBT
NCT05112523 ·Status: UNKNOWN
-
Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue
NCT02379429 ·Status: RECRUITING
-
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
NCT01050504 ·Status: RECRUITING
-
Guiding Value of Urinary Tumor DNA Testing in Cystoscopy for High-Risk/Very High-Risk Non-Muscle-Invasive Bladder Cancer
NCT07180212 ·Status: RECRUITING ·Phase: NA
-
A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma
NCT06178601 ·Status: RECRUITING ·Phase: PHASE2
-
Assessement of the Concordance of Genomic Alterations Between Urine and Tissue in High-Risk NMIBC Patients
NCT04412070 ·Status: TERMINATED
-
A Study of Postoperative Adjuvant Chemotherapy for Upper Urinary Urothelial Carcinoma With Lymphovascular Invasion
NCT04255771 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study Comparing the Necessity of a Second Transurethral Resection in High-Risk Non-Muscle-Invasive Bladder Cancer Patients With Negative Results From Post-Initial Resection Urine Genome-Wide Low-Depth Sequencing
NCT07036731 ·Status: RECRUITING ·Phase: NA
-
A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
NCT03809013 ·Status: COMPLETED ·Phase: PHASE2
-
Analysis of Urinary Methylation Patterns Via Liquid Biopsy as an Early Diagnosis Tool
NCT06878027 ·Status: RECRUITING
-
The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection
NCT06287541 ·Status: RECRUITING ·Phase: NA
-
The Research Value of Multi-omics and Multi-modal Information in the Diagnosis and Treatment of Urinary System Tumors
NCT06490211 ·Status: RECRUITING
-
A Clinical Trial Aimed At Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer
NCT06632964 ·Status: RECRUITING ·Phase: PHASE1
-
Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
NCT00872495 ·Status: RECRUITING
-
Neoadjuvant PD-1 Monoclonal Antibody Plus Cisplatin-based Chemotherapy in Locally Advanced Upper Tract Urothelial Carcinoma
NCT04672317 ·Status: UNKNOWN ·Phase: PHASE2