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Novel Urine DNA Methylation Assay Under Study in Bladder Cancer

By: Hope Craig, MSPH
Posted: Friday, November 6, 2020

DNA methylation may prove to be a more rapid and noninvasive approach to the detection and surveillance of bladder cancer compared with existing methods, according to a research article published in The Journal of Clinical Investigation. Using combined analyses from three large cohort studies, Xu Chen, PhD, and colleagues of Sun Yat-Sen University in Guangzhou, China, identified 26 methylation markers of bladder cancer and developed a diagnostic model with potential, especially in the detection of low-grade tumors. To validate its clinical applicability, a multicenter clinical trial is ongoing (ClinicalTrials.gov identifier NCT04314245).

“Our approach achieved a great improvement in sensitivity over urine cytology and fluorescent in situ hybridization, especially in the detection of early-stage, minimal, residual and recurrent tumors. Therefore, it is adopted in the optional clinical detection of bladder cancer by more than 10 hospitals in China,” wrote the authors.

The diagnostic model was tested in more than 300 samples and validated in 175 samples. The two-marker model showed high accuracy (87%), sensitivity (90%), and specificity (83%). Furthermore, the assay was found to be three to four times more sensitive than fluorescent in situ hybridization and cytology, respectively, in the detection of low-grade tumors. “The urine diagnostic score from this assay was better associated with tumor malignancy and burden,” the researchers commented.

In sum, the authors believe their urine tumor DNA methylation assay may reduce the burden of cystoscopy as well as blind second surgery. However, although DNA-methylation assays have shown promise for monitoring bladder cancer recurrence in large cohorts in Europe, they still need to be validated in large-scale cohorts in Asia to be adopted into routine clinical practice.

Disclosure: The authors reported no conflicts of interest.



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