Clinical trial · Observational
Multi Institutional Study in Patient Presenting With Hematuria
Multi Institutional Study To Evaluate Dna Methlyation Markers For Detection Of Primary Bladder Cancer In Urine Samples From A Cohort Of Patients With Hematuria
NCT03122964CI-TRIAL-00037470unknownClinicalTrials.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 evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
Conditions
Conditions (2)
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 |
| Hematuria | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AssureMDx | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with gross or microscopic hematuria
- description
- This study aims to prospectively enroll a minimum of 700 subjects, with gross or microscopic hematuria. Each site will target enrollment of 100 subjects and patient samples will be collected from consecutive patients meeting the inclusion criteria outlined below. The total study duration is expected to be 24 months.
- interventionNames
- Diagnostic Test: AssureMDx
Primary outcomes (1)
- measure
- Performance of a panel of methylation markers for the detection of bladder cancer in patient presenting with hematuria.
- timeFrame
- 1 year
- description
- Early detection of bladder cancer in patients presenting with hematuria
Secondary outcomes (1)
- measure
- Predictiveness of a panel of methylation markers combined with clinical risk factors for the detection of bladder cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is willing and able to give written informed consent 2. Subject presents with or has a history of gross hematuria or microhematuria within the last 3 months Exclusion Criteria: 1. Subject has an active urinary tract infection, current urinary retention, active stone disease (renal or bladder), current ureteral stents or nephrostomy tubes, prior bowel interposition, or recent genitourinary instrumentation (within 10 days) 2. Subject has a current or past history of genitourinary or urologic cancer within 5 years 3. Subject has an active (untreated) cancer of any type, except basal cell skin cancer within 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.