Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Upper Tract Urothelial Carcinoma
- Sponsor
- AnchorDx Medical Co., Ltd.
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- Efficacy of urine DNA methylation/somatic mutation test
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Case group:
- •1.Any male or female patient aged 18 or older.
- •2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
- •4.Able to provide legally effective informed consent.
- •Control group:
- •1.Any male or female patient aged 18 or older.
- •2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
- •4.Able to provide legally effective informed consent.
Exclusion Criteria
- •1.Patients had been diagnosed with cancer history.
- •2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
Outcomes
Primary Outcomes
Efficacy of urine DNA methylation/somatic mutation test
Time Frame: 1 Year
Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)