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

Upper Tract Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948528
• Other study ID #: AnchorDx BC006
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: AnchorDx Medical Co., Ltd.
• Contact: Xu Chen, MD
• Phone: +86-13430306339
• Email: chenx457[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 31, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Upper Tract Urothelial Carcinoma

Intervention

Other:
• Active Comparator: Surgery Pathology or Cystoscopy
Case group will be followed up with surgery pathology or cystoscopy.
• Active Comparator: Clinical Diagnosis
Control group will be diagnosed in clinical.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou

Sponsors (9)

Lead Sponsor	Collaborator
AnchorDx Medical Co., Ltd.	First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, Peking University First Hospital, Peking University Third Hospital, Sir Run Run Shaw Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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