A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

A Multicenter, Single-blind, Observational Clinical Trial of URISAFE

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Urothelial Carcinoma; Urocystitis; Urinary Bladder Stone
• Intervention / Treatment: Diagnostic test: Urine DNA methylation analysis; Procedure: medical imaging and/or cystoscopy and/or pathological examination

Detailed Description

In this clinical trial, the testing kit to be evaluated is a Human Multigene Methylation Detection Kit (Fluorescent PCR Method), which is intended to qualitatively detect methylation levels of multiple genes in human urine specimen in vitro by Fluorescent PCR Method, and the standard method used in clinical diagnostic includes medical imaging, cystoscopy, pathological examination.

Subjects will provided urine specimen as required for the evaluation of the testing kit followed by a examination of standard method. Technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis.

The results of the testing kit will be compared with the standard method, and the effectiveness of the Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for bladder cancer detection under normal clinical use will be assessed through statistical analysis.

• Study Type: Observational
• Enrollment (Estimated): 482

Contacts and Locations

• Study Contact: Name: Xianshu Wang, PhD; Phone Number: 86-01-18819269978; Email: xianshuwang@creativebio.cn
• Study Contact Backup: Name: Chunhua Chen; Phone Number: 86-01-13560141654; Email: chenchunhua@creativebio.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Huang; Phone Number: +86-10-88196023; Email: gcp_xy01@bjcancer.org
      • Principal Investigator: Peng Du, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects without age limit, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. 482 subjects are targeted to enroll.

Description

Inclusion Criteria:

• Subject must meet all three of the following criteria to be eligible for the study:

  1. Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
  2. Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;

  3. Any subject who is required to meet any of the following conditions:

     1. Who is diagnosed with or suspected of bladder cancer.
     2. Who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.).
     3. Who has hematuria symptoms (such as cystitis, stones, etc.).
     4. Who has other diseases that can be easily confused with bladder cancer.

Exclusion Criteria:

• Subject with any of the following conditions shall be excluded:

  1. Who has undergone surgery or chemoradiotherapy.
  2. Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bladder cancer group; Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method.	Diagnostic test: Urine DNA methylation analysis; Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method); Other Names: URISAFE; Procedure: medical imaging and/or cystoscopy and/or pathological examination; Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
The normal group; Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method.	Diagnostic test: Urine DNA methylation analysis; Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method); Other Names: URISAFE; Procedure: medical imaging and/or cystoscopy and/or pathological examination; Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.	One year
Specificity	Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.	One year
Consistency Rate	Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.	One year
Kappa Coefficient	Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.	One year

Collaborators and Investigators

• Sponsor: Creative Biosciences (Guangzhou) Co., Ltd.
• Collaborators: Guangzhou Xiangkang Medical Research Co., Ltd.
• Investigators: Principal Investigator: Peng Du, PhD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): April 15, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Urothelial Carcinoma; Bladder Cancer; Cancer Screening; Gene Methylation Biomarkers; Multigene Methylation Detection; Urine DNA Test
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Urinary Bladder Calculi
• Other Study ID Numbers: KLM2021-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Undecided

We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.

Drug and device information, study documents

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