Clinical trial · Observational
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for the Detection of Urothelial Carcinoma
NCT04314245CI-TRIAL-00066663completedClinicalTrials.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 evaluate the performance characteristics(sensitivity and specificity) of AnchorDx's urine DNA methylation/somatic mutation profiling assay for detecting urothelial carcinoma compared to pathology in patients.
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 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Clinical Diagnosis | Other | — | UNRESOLVED |
| Active Comparator: Pathology | Other | — | UNRESOLVED |
| Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Urothelial carcinoma group
- description
- Subjects who diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgical pathology.
- interventionNames
- Other: Active Comparator: Pathology
- Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay
- label
- interference group
- description
- Subjects who diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgical pathology.
- interventionNames
- Other: Active Comparator: Pathology
- Other: Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay
- label
- Control group
- description
- Subjects who clinically diagnosed with benign disease of the urinary system, such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Urothelial carcinoma group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with incident or recurrent urothelial carcinoma (including bladder/ureter/renal pelvis) by surgery. 2. interference group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with incident or recurrent bladder cancer other than urothelial carcinoma (including bladder squamous cell carcinoma/bladder adenocarcinoma/other bladder-related cancers/prostate cancer/rectal cancer) by surgery. 3. Control group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments. * Diagnosed with urinary disease such as Urinary calculi, urinary tract infection (except urinary tuberculosis), benign prostatic hyperplasia, glandular cystitis. All enrollee are able to provide legally effective informed consent. 4. Healthy volunteers group: * Any male or female patient aged 18 or older. * Able to provide urine specimen (100ml for both first void and non-first-void urine) before physical examination. exclusion criteria: 1. Urothelial carcinoma/Interference group/Control group * Has had diagnosed with other cancers. * Patients diagnosed with non-urological cancer. * Failed to provide a written informed consent. 2. Healthy volunteers group: * Volunteers with abnormal test results of urine analysis or urological ultrasound test. * Volunteers sceptical of cancers from non-urological origin in a normal results of urine analysis or urological ultrasound. * Failed to provide legally effective informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.