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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Upper Tract Urothelial Carcinoma

Intervention / Treatment
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* Other: Active Comparator: Surgery Pathology or Cystoscopy
* Other: Active Comparator: Clinical Diagnosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group:<br>All suspected upper tract urothelial carcinoma participants will be assigned to case group. | Other: Active Comparator: Surgery Pathology or Cystoscopy<br>* Case group will be followed up with surgery pathology or cystoscopy.<br>|
| Control group<br>All suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group. | Other: Active Comparator: Clinical Diagnosis<br>* Control group will be diagnosed in clinical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of urine DNA methylation/somatic mutation test | Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology) | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper tract urothelial carcinoma, urine, DNA methylation, somatic mutation