A urine-based DNA methylation assay to facilitate early detection and risk stratification of bladder cancer.

ABSTRACT:

Background

Current non-invasive tests have limited sensitivities and lack capabilities of pre-operative risk stratification for bladder cancer (BC) diagnosis. We aimed to develop and validate a urine-based DNA methylation assay as a clinically feasible test for improving BC detection and enabling pre-operative risk stratifications.

Methods

A urine-based DNA methylation assay was developed and validated by retrospective single-center studies in patients of suspected BC in Cohort 1 (n = 192) and Cohort 2 (n = 98), respectively. In addition, a prospective single-center study in hematuria patient group (Cohort 3, n = 174) was used as a second validation of the model.

Results

The assay with a dual-marker detection model showed 88.1% and 91.2% sensitivities, 89.7% and 85.7%

SUBMITTER: Ruan W 

PROVIDER: S-EPMC8072728 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature