An observational study in Bladder Cancer, Urocystitis and Urinary Bladder Stone, sponsored by Creative Biosciences (Guangzhou) Co., Ltd.. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Creative Biosciences (Guangzhou) Co., Ltd. · Observational
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 482 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Creative Biosciences (Guangzhou) Co., Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Subject must meet all three of the following criteria to be eligible for the study:
Any subject who is required to meet any of the following conditions:
Exclusion Criteria:
Subject with any of the following conditions shall be excluded:
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 · Procedure: medical imaging and/or cystoscopy and/or pathological examination
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 · Procedure: medical imaging and/or cystoscopy and/or pathological examination
Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
Also known as: URISAFE
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
Sensitivity
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Time frame: One year
Specificity
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Time frame: One year
Consistency Rate
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Time frame: 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.
Time frame: One year
Plan to share: Undecided — Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
No publications or documents are linked to this record.
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Creative Biosciences (Guangzhou) Co., Ltd.