ArticleBJUI compass2026
Validation of the diagnostic accuracy of a urine-based DNA methylation marker test in patients with upper urinary tract lesions.
Article in BJUI compass, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Noninvasive differentiation of upper tract urothelial carcinoma and renal cell carcinoma in challenging renal lesions using urinary DNA methylation.BJUI compass · 2026Article
- Validation of the diagnostic accuracy of a urine-based DNA methylation marker test in patients with upper urinary tract lesions.BJUI compass · 2026Article
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
Objectives: This study aims to validate the diagnostic accuracy of a novel urine-based DNA methylation test in patients with suspected upper tract urothelial carcinoma (UTUC) on CT urography and to assess its potential to eliminate the need for diagnostic ureterorenoscopy (URS) in selected patients, expedite treatment and identify high-grade tumours suitable for neoadjuvant chemotherapy. Patients and Methods: We prospectively collected urine samples from 46 consecutive patients with suspected UTUC in computed tomography and analysed them using the Bladder CARE™ methylation test. Test performance was evaluated against final pathology from URS biopsies and/or surgical specimens. We performed Youden Index analysis to optimise diagnostic cut-off values and assessed correlations between Bladder CARE Index (BCI) levels and tumour characteristics, particularly grade differentiation. Results: Using the manufacturer's cut-off (BCI > 2.5), the test demonstrated 95% sensitivity, 69% specificity, 70% positive predictive value and 95% negative predictive value (NPV), significantly outperforming cytology (11% sensitivity). An optimised, study-derived cut-off (4.35) further improved specificity to 92% with sensitivity and NPV remaining ≥95%. Importantly, a higher threshold (BCI > 10) yielded 100% specificity and 100% PPV, although at the expense of sensitivity (65%). Median BCI values differed between high-grade (38.6) and low-grade tumours (9.45), suggesting utility for non-invasive grade assessment. BCI also correlated with tumour size (β = 12 mm per log10 increase, Conclusion: This novel urine-based DNA methylation test offers high diagnostic accuracy for UTUC detection. However, clinical interpretation should be threshold dependent. While BCI values >2.5 show high sensitivity, the PPV of 70% indicates a relevant proportion of false-positive results, and diagnostic URS remains warranted in this range. In contrast, high positive values (BCI > 10) demonstrated 100% specificity and PPV and could enable direct progression to definitive surgery without diagnostic URS, avoiding procedure-related complications and expediting treatment. The correlation with tumour grade addresses a critical need for identifying candidates for neoadjuvant chemotherapy without invasive tissue diagnosis.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.