Bladder CancerNCT05337189
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
An observational study of Bladder Cancer and Urocystitis, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site in China.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer, Urocystitis, Urinary Bladder Stone
- What is being tested?
- Urine DNA methylation analysis and medical imaging and/or cystoscopy and/or pathological examination
- Type of treatment
- Surgery or procedure
- How many people
- 482 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Subject must meet all three of the following criteria to be eligible for the study:
- Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
- Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
- Any subject who is required to meet any of the following conditions:
- Who is diagnosed with or suspected of bladder cancer.
- 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.).
- Who has hematuria symptoms (such as cystitis, stones, etc.).
- Who has other diseases that can be easily confused with bladder cancer.
Who cannot join
- Subject with any of the following conditions shall be excluded:
- Who has undergone surgery or chemoradiotherapy.
- Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jun Huang, +86-10-88196023, gcp_xy01@bjcancer.org
Peng Du, PhD
About this study
Official title: 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).
Read the 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.
- Being tested
- Urine DNA methylation analysis, medical imaging and/or cystoscopy and/or pathological examination
- Keywords
- Bladder Cancer, Urine DNA Test, Gene Methylation Biomarkers, Multigene Methylation Detection, Cancer Screening, Urothelial Carcinoma
- Medical subject headings
- Urinary Bladder Neoplasms, Cystitis, Urinary Bladder Calculi, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine DNA methylation analysisDiagnostic test
Also called URISAFE
Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)
medical imaging and/or cystoscopy and/or pathological examinationProcedure or surgery
Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Urine DNA methylation analysis; Procedure: 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. Receives: Diagnostic Test: Urine DNA methylation analysis; Procedure: medical imaging and/or cystoscopy and/or pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Measured: One year
Specificity
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Measured: One year
Consistency Rate
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start9 Mar 2022
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Xiangkang Medical Research Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Peng Du, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337189
- Sponsor's protocol ID
- KLM2021-04
- Status last verified
- Jun 2024
- First submitted
- 13 Apr 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-blind, Observational Clinical Trial of URISAFE
- ClinicalTrials.gov ID
- NCT05337189
- Acronym / sponsor ID
- KLM2021-04
- Keywords
- Bladder Cancer, Urine DNA Test, Gene Methylation Biomarkers, Multigene Methylation Detection, Cancer Screening, Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Creative Biosciences (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Guangzhou Xiangkang Medical Research Co., Ltd.
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer group | – | Diagnostic Test: Urine DNA methylation analysis, Procedure: medical imaging and/or cystoscopy and/or pathological examinationTwo 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. |
| The normal group | – | Diagnostic Test: Urine DNA methylation analysis, Procedure: medical imaging and/or cystoscopy and/or pathological examinationTwo 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Subject must meet all three of the following criteria to be eligible for the study:
Key exclusion criteria (3 listed)
- Subject with any of the following conditions shall be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine DNA methylation analysisAlso: URISAFEUrine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) | Diagnostic test | Bladder cancer group, The normal group |
| medical imaging and/or cystoscopy and/or pathological examinationSubjects will undergo medical imaging and/or cystoscopy and/or pathological examination | Procedure or surgery | Bladder cancer group, The normal group |
Primary outcome
Sensitivity
Time frame: One year
Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.
Specificity
Time frame: One year
Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.
Consistency Rate
Time frame: One year
Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.
Kappa Coefficient
Time frame: One year
Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided. Undecided We are carefully considering all applicable regulations and laws governing sharing of patients' data from China online with the global public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Du, PhD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and Urocystitis, run by Creative Biosciences (Guangzhou) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianshu Wang, PhD (86-01-18819269978, xianshuwang@creativebio.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.