Clinical trial · Observational
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection
NCT04948528CI-TRIAL-00066650unknownClinicalTrials.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)
Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.
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 |
|---|---|---|---|
| Upper Tract Urothelial Carcinoma | Renal Pelvis and Ureter Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Clinical Diagnosis | Other | — | UNRESOLVED |
| Active Comparator: Surgery Pathology or Cystoscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case group:
- description
- All suspected upper tract urothelial carcinoma participants will be assigned to case group.
- interventionNames
- Other: Active Comparator: Surgery Pathology or Cystoscopy
- label
- Control group
- description
- All suspected upper tract urothelial benign participants such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis will be assigned to control group.
- interventionNames
- Other: Active Comparator: Clinical Diagnosis
Primary outcomes (1)
- measure
- Efficacy of urine DNA methylation/somatic mutation test
- timeFrame
- 1 Year
- description
- Sensitivity and specificity of urine DNA methylation/somatic mutation test (the proportion of pathology that are correctly identified as such by pathology)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Case group: * 1.Any male or female patient aged 18 or older. * 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * 3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery. * 4.Able to provide legally effective informed consent. Control group: * 1.Any male or female patient aged 18 or older. * 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * 3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis. * 4.Able to provide legally effective informed consent. Exclusion Criteria: * 1.Patients had been diagnosed with cancer history. * 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
References
Publications (0)
Data not yet available
No reference posted for this study.