Clinical trial · Observational
A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China
A Multicenter, Single-blind, Observational Clinical Trial of URISAFE
NCT05337189CI-TRIAL-00085950unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Bladder Stone | — | UNRESOLVED | — |
| Urocystitis | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medical imaging and/or cystoscopy and/or pathological examination | Procedure | — | UNRESOLVED |
| Urine DNA methylation analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Diagnostic Test: Urine DNA methylation analysis
- Procedure: medical imaging and/or cystoscopy and/or pathological examination
- label
- 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.
- interventionNames
- Diagnostic Test: Urine DNA methylation analysis
- Procedure: medical imaging and/or cystoscopy and/or pathological examination
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.