Clinical trial · Observational
Urine-DNA Biomarkers in Detecting Bladder Cancer
Detection of Bladder Cancer Using Urinary Cell-free DNA and Cellular DNA
- 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)
DNA biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. Many genetic alterations have been identified in the urinary DNA. However, not all bladder tumors harbor mutations in the most commonly altered oncogenes. Thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. The investigators will conduct a prospective evaluation of a panel of mutations in urine-DNA test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.
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 |
|---|---|---|---|
| Biomarker | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Diagnosis | — | UNRESOLVED | — |
| Urine | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next generation sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Diagnosed Urinary Bladder Cancers
- description
- Patients who are being monitored for bladder cancer will be the experimental group to test the urine-DNA by next generation sequencing for bladder cancer biomarkers
- interventionNames
- Diagnostic Test: Next generation sequencing
- label
- Non-Urinary Bladder Cancers
- description
- Patients being treated for gross hematuria will provide a negative control to provide data from testing by next generation sequencing for biomarkers in patients being treated for other diseases.
- interventionNames
- Diagnostic Test: Next generation sequencing
Primary outcomes (4)
- measure
- sensitivity of urinalysis by Urine-DNA test
- timeFrame
- through study completion, an average of 8 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with gross hematuria or other clinical sympton suspected of bladder cancer. * male or female patients aged \>= 18 years. * available tumor tissue, urine and blood sample. * signed informed consent form. Exclusion Criteria: * prior diagnosis of cancer except bladder cancer * age under 18 years * individuals unwilling to sign the IRB-approved consent form * comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.
References
Publications (0)
Data not yet available