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

Recruiting

• Conditions: Upper Tract Urothelial Carcinoma

• Registration Number: NCT04948528
• Lead Sponsor: AnchorDx Medical Co., Ltd.

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-27
• Study First Posted: 2021-07-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24
• Primary Completion: 2023-06-25
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of urine DNA methylation/somatic mutation test	1 Year	Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, China