Observational studyJournal of hematology & oncology2026
Clinical validation of UroCAD test for upper tract urothelial carcinoma detection: results from a prospective multi-center study.
Observational study in Journal of hematology & oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05043662 (A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Who cites it
2 citing papers in PubMed.
- Comparative insights into upper tract urothelial carcinoma: Aligning Chinese Urological Association and European Association of Urology guidelines with clinical practice.Asian journal of urology · 2026Article
- Liquid biopsy-guided kidney-sparing management in upper tract urothelial carcinoma: from preoperative risk stratification to perioperative surveillance.Frontiers in oncology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUpper tract urothelial carcinoma (UTUC) poses diagnostic challenges due to its anatomical complexity and limited accessibility.
methodsThis prospective multicenter study (NCT05043662) evaluated the diagnostic performance of UroCAD, a novel non-invasive assay based on chromosomal copy number variation (CNV) analysis, in 244 patients with suspected UTUC or benign upper urinary tract conditions.
resultsUrine samples were analyzed for arm-level chromosomal aberrations (|Z-score|≥ 3.21), with histopathology as the reference standard. UroCAD demonstrated excellent diagnostic accuracy: sensitivity 91.0%, specificity 97.0%, and overall accuracy 93.4%. Performance was consistent across tumor locations (renal pelvis: 96.8%, ureter: 86.4%) and grades (high-grade: 93.5%, low-grade: 76.2%). Compared to urine cytology, UroCAD showed significantly higher sensitivity (91.2% vs. 52.9%, P < 0.001). CNV profiling revealed grade-associated patterns, with high-grade tumors frequently exhibiting amplifications on 1q and 8q. The extent (MaxZ) and number (CountZ) of chromosomal alterations correlated positively with tumor grade, supporting UroCAD's potential utility in molecular grading. CONCLUSIONS AND CLINICAL IMPLICATIONS: The UroCAD test demonstrates robust diagnostic performance for UTUC detection with high specificity and high sensitivity. The consistent performance across various clinical scenarios and the identification of specific chromosomal alteration patterns support its potential as a valuable clinical tool for both initial diagnosis and treatment monitoring. These findings warrant larger-scale validation studies to confirm its utility in routine clinical practice.
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