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

Creative Biosciences

Status: Enrolling

Conditions: Bladder Cancer; Urinary Bladder Stone; Urothelial Carcinoma; Urocystitis

Treatments: Procedure: medical imaging and/or cystoscopy and/or pathological examination; Diagnostic Test: Urine DNA methylation analysis

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05337189

KLM2021-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 482 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

482 participants in 2 patient groups

Bladder cancer group

Description:

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.

Treatment:

Diagnostic Test: Urine DNA methylation analysis

Procedure: medical imaging and/or cystoscopy and/or pathological examination

The normal group

Description:

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.

Treatment:

Diagnostic Test: Urine DNA methylation analysis

Procedure: medical imaging and/or cystoscopy and/or pathological examination