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

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.

Study Overview

• Status: Recruiting
• Conditions: Upper Tract Urothelial Carcinoma
• Intervention / Treatment: Other: Active Comparator: Surgery Pathology or Cystoscopy; Other: Active Comparator: Clinical Diagnosis

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 Type: Observational
• Enrollment (Anticipated): 490

Contacts and Locations

• Study Contact: Name: Xu CHEN, MD; Phone Number: +86-13430306339; Email: chenx457@mail.sysu.edu.cn
• Study Contact Backup: Name: Xia Li; Phone Number: +86-15902059556; Email: xia_li@anchordx.com

Study Locations

• China
  • Guangzhou, China, 510120
    • Recruiting
    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • Principal Investigator: Liqun ZHOU, MD
    • Sub-Investigator: Yanqing GONG, MD
    • Contact: Xu CHEN, MD; Phone Number: +86-13430306339; Email: chenx457@mail.sysu.edu.cn
    • Principal Investigator: Jian Huang, MD
    • Sub-Investigator: Xu CHEN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

suspected upper tract urothelial carcinoma patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group: All suspected upper tract urothelial carcinoma participants will be assigned to case group.	Other: Active Comparator: Surgery Pathology or Cystoscopy; Case group will be followed up with surgery pathology or cystoscopy.
Control group; 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; Control group will be diagnosed in clinical.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AnchorDx Medical Co., Ltd.
• Collaborators: Peking University First Hospital; Peking Union Medical College Hospital; Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; The Affiliated Hospital of Qingdao University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Affiliated Hospital of Zhengzhou University; Sir Run Run Shaw Hospital
• Investigators: Study Chair: Jian HUANG, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): June 25, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: urine; DNA methylation; upper tract urothelial carcinoma; somatic mutation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: AnchorDx BC006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No