Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urinary Bladder Calculi

Calculi

Cystitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Urolithiasis

Urinary Calculi

Pathological Conditions, Anatomical

Transitional Cell Carcinoma

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.

Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

Urine DNA methylation analysis

Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

medical imaging and/or cystoscopy and/or pathological examination

Xianshu Wang, PhD

Chunhua Chen

Jun Huang

Peng Du, PhD

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).

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.

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

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

Undecided

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

Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.

Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.

Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.

Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China	NCT05337189	Bladder Cancer Urocystitis Urinary Bladder... Urothelial Carc...	Urine DNA methy... medical imaging...	-	Creative Biosciences (Guangzhou) Co., Ltd.
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China	NCT05337189	Bladder Cancer Urocystitis Urinary Bladder... Urothelial Carc...	Urine DNA methy... medical imaging...	-	Creative Biosciences (Guangzhou) Co., Ltd.

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