Clinical trial · Observational
UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
- 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)
Upper tract urothelial carcinoma (UTUC) diagnosis include urography using computed tomography urography (CTU) or urography using MRI (MRU). The sensitivity of CTU decreases substan¬tially with decreasing lesion size. Other drawbacks of CTU include the radiation exposure and potential adverse effects in patients with allergic reactions or pre-existing renal impairment. In terms of urine cytology, the major drawbacks of urine cytology are low sensitivity and highly dependent of the experience and skills of the cytopathologist. We here intended to investigate whether UroCAD can be added in the diagnostic work-up of UTUC patient, and improve the accuracy of predicting UTUC before surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytology | — | UNRESOLVED | — |
| Diagnoses Disease | — | UNRESOLVED | — |
| IMAGE | — | UNRESOLVED | — |
| Ureter Cancer | Malignant Ureter Neoplasm | CURATED_BROADER | 0.80 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UroCAD assay, CTU examination and urine cytology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Urothelial carcinoma group
- description
- The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. CTU and cytology will be performed according to the routine of clinical practice (N=80).
- interventionNames
- Diagnostic Test: UroCAD assay, CTU examination and urine cytology
- label
- Control group
- description
- Patients need to undergo CTU examination and being treated for benign diseases with ureteroscopy, but without any tumor will provide a negative control to provide data for determining the sensitivity and specificity of UroCAD, CTU and cytology assay (N=30).
- interventionNames
- Diagnostic Test: UroCAD assay, CTU examination and urine cytology
Primary outcomes (1)
- measure
- Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients suspected with UTUC and planned to undergo surgery such as such ureteroscopy or radical nephroureterectomy. Participants without any tumor disease and willing to attend the study by providing morning urine. Male or female patients aged \>= 18 years. Participants signed informed consent form. Exclusion Criteria: Individuals unwilling to sign the consent form or unwilling to provide morning urine for test or unwilling to provide the medical record. Patient already received suprapubic cystostomy or urethral catheterization. Participants with late-stage uremia and need regular dialysis. Participants with reasons like elevated serum creatinine, allergy to intravenous CT contrast media et al, and unable to undergo CTU. Patient with cancer other than urothelial carcinoma.
References
Publications (3)
- BACKGROUNDBaard J, de Bruin DM, Zondervan PJ, Kamphuis G, de la Rosette J, Laguna MP. Diagnostic dilemmas in patients with upper tract urothelial carcinoma. Nat Rev Urol. 2017 Mar;14(3):181-191. doi: 10.1038/nrurol.2016.252. Epub 2016 Dec 13. PMID 27958391
- BACKGROUNDJanisch F, Shariat SF, Baltzer P, Fajkovic H, Kimura S, Iwata T, Korn P, Yang L, Glybochko PV, Rink M, Abufaraj M. Diagnostic performance of multidetector computed tomographic (MDCTU) in upper tract urothelial carcinoma (UTUC): a systematic review and meta-analysis. World J Urol. 2020 May;38(5):1165-1175. doi: 10.1007/s00345-019-02875-8. Epub 2019 Jul 18. PMID 31321509
- RESULTZeng S, Ying Y, Xing N, Wang B, Qian Z, Zhou Z, Zhang Z, Xu W, Wang H, Dai L, Gao L, Zhou T, Ji J, Xu C. Noninvasive Detection of Urothelial Carcinoma by Cost-effective Low-coverage Whole-genome Sequencing from Urine-Exfoliated Cell DNA. Clin Cancer Res. 2020 Nov 1;26(21):5646-5654. doi: 10.1158/1078-0432.CCR-20-0401. Epub 2020 Oct 9. PMID 33037018