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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337189
• Other study ID #: KLM2021-04
• Status: Recruiting
• Start date: March 9, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2023
• Source: Creative Biosciences (Guangzhou) Co., Ltd.
• Contact: Xianshu Wang, PhD
• Phone: 86-01-18819269978
• Email: xianshuwang[@]creativebio.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 482
• Est. completion date: July 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

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)

Procedure:
• medical imaging and/or cystoscopy and/or pathological examination
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Creative Biosciences (Guangzhou) Co., Ltd.	Guangzhou Xiangkang Medical Research Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.	One year
Primary	Specificity	Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.	One year
Primary	Consistency Rate	Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.	One year
Primary	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