Clinical trial · Interventional
Novel Urine-Based DNA Methylation Biomarkers for Urothelial Bladder Carcinoma Detection in Patients With Hematuria
NCT05362539CI-TRIAL-00058271completedN/AClinicalTrials.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 current study aimed to assess the diagnostic performance of novel urine-based DNA hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) for UBC detection in patients with hematuria.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed tomography | Diagnostic Test | — | UNRESOLVED |
| Cystoscopy | Procedure | — | UNRESOLVED |
| DNA hypermethylation assay | Genetic | — | UNRESOLVED |
| Urine cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hematuria patients
- description
- Voided urine was collected from consecutive patients presented with hematuria at our institute for urine cytology and DNA hypermethylation assay of the assigned genes using methylation-specific Polymerase Chain Reaction (PCR). Further assessment by office cystoscopy and imaging with subsequent inpatient cystoscopic biopsy for positive findings, was done. The diagnostic characteristics of DNA hypermethylation and urine cytology were assessed based on its capability to predict UBC noninvasively
- interventionNames
- Procedure: Cystoscopy
- Diagnostic Test: Computed tomography
- Genetic: DNA hypermethylation assay
- Diagnostic Test: Urine cytology
Primary outcomes (1)
- measure
- Rate of hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) in patients with urothelial bladder carcinoma
- timeFrame
- 4 weeks
- description
- Rate of hypermethylation of six genes (GATA4, P16, P14, APC, CDH1 and CD99) in patients with urothelial bladder carcinoma
Eligibility
Eligibility (as posted)
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with hematuria (macroscopic or microscopic) Exclusion Criteria: * history of Bladder Cancer * history of pelvic irradiation, * bleeding diathesis or receiving anticoagulants * patients with upper urinary tract neoplasm or urolithiasis
References
Publications (0)
Data not yet available
No reference posted for this study.