Clinical trial · Observational
UroCAD for Hematuria Evaluation--A Prospective, Multi-center Study
Hematuria Evaluation by Whole-genome Sequencing of Urine-Exfoliated Cell DNA, A Prospective, Multi-center Study
- 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)
Hematuria is recognized as an important sigh of potential urinary tract malignancy. Therefore, understanding the disease processes and discovering the potential urothelial carcinoma (UC) underlying this important sign is critical. Cystoscopy, urine cytology and imaging are most reliable methods for UC diagnosis, but certain drawbacks exist for these methods, such as invasiveness or inaccuracy. Chromosomal instability (CIN) is a hallmark of human cancer, and it's related with tumor stage and grade. Previous research has proved that analyzing CIN of the DNA extracted from urothelial cells in urine samples seems a promising method for detecting UC. Here we intend to assess CIN's performance for hematuria evaluation.
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 |
|---|---|---|---|
| Hematuria | — | UNRESOLVED | — |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| urine sample collection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Hematuria patients
- description
- Hematuria patients (≥ 3 RBCs/HPF) with treatment-naïve, pathology-confirmed urothelial carcinoma or benign genitourinary system disease or with undetermined lesion presented with hematuria.
- interventionNames
- Diagnostic Test: urine sample collection
- label
- Non-hematuria patients
- description
- Patients without hematuria and diagnosed with pathology-confirmed cancer other than urothelial cancer.
- interventionNames
- Diagnostic Test: urine sample collection
Primary outcomes (4)
- measure
- sensitivity
- timeFrame
- through study completion, an average of 8 months
- description
- Comparison of the sensitivity of the UroCAD analysis versus clinically-acceptable threshold, defined as 75%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants aged ≥ 18 years and signed informed consent form. * Participants presented with hematuria (≥ 3 RBCs/HPF) and meet one of the following criteria: 1. Patients recommended to undergo cystoscopy or ureteroscopy; 2. Patients with treatment-naïve, pathology-confirmed urothelial carcinoma; 3. Patients diagnosed with benign genitourinary disease. * Participants diagnosed with cancer other than urothelial carcinoma. Exclusion Criteria: * Participants with history of urothelial carcinoma. * Participants with urothelial carcinoma accompanied by other malignancy. * Individuals unwilling to sign the consent form or unwilling to provide urine sample for test or quality of urine sample is poor. * Patients unsuitable for this clinical trial.
References
Publications (2)
- BACKGROUNDSansregret L, Vanhaesebroeck B, Swanton C. Determinants and clinical implications of chromosomal instability in cancer. Nat Rev Clin Oncol. 2018 Mar;15(3):139-150. doi: 10.1038/nrclinonc.2017.198. Epub 2018 Jan 3. PMID 29297505
- BACKGROUNDMcDougal, W. Scott, et al. Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences, 2015.