Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urothelial Carcinoma
- Sponsor
- AnchorDx Medical Co., Ltd.
- Enrollment
- 1170
- Locations
- 1
- Primary Endpoint
- Diagnostic Performance for the detection of urothelial carcinoma
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Urothelial carcinoma group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery.
- •interference group:
- •Any male or female patient aged 18 or older.
- •Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
- •Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery.
- •Control group:
- •Any male or female patient aged 18 or older.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Diagnostic Performance for the detection of urothelial carcinoma
Time Frame: 1 Years
The efficacy of the urine DNA methylation/somatic mutation profiling assay for the detection of urothelial carcinoma comparing with pathologic diagnosis, including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (+LR), negative likelihood ratio (-LR) and accuracy.
Secondary Outcomes
- Sensitivity and Specificity in different pathological stages and histologic grades of urothelial carcinoma(1 Years)