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Relevance: According to the International Agency for Research on Cancer (IARС), lung cancer (LC) today ranks first in cancer&#x0D;incidence worldwide [1]. In the Republic of Kazakhstan, about 3800 new cases of LC and more than 2000 deaths from LC are&#x0D;registered each year (one-year mortality exceeds 49.4%) [2]. This supports the relevance of early LC diagnostics. The study of&#x0D;DNA methylation in human peripheral blood mononuclear cells (PBMC) suggests its use as an early diagnostic and prognostic&#x0D;marker for LC before detecting a malignant neoplasm by visual diagnostic methods.&#x0D;The purpose of the study was to find specific diagnostic and prognostic markers by DNA methylation profiling of PBMC&#x0D;in patients with LC.&#x0D;Results: Methylation markers of blood mononuclear fraction were detected in CG islets associated with genes ICAM5,&#x0D;mir138, SYNE1, and KLK4 in 97% of plasma samples from patients with LC and were absent in healthy people. The usability of&#x0D;these markers to differentiate LC from 16 other cancers using NCBI GEO and TCGA methylation data was demonstrated with a&#x0D;specificity level of 0.96 and a sensitivity of 0.84.&#x0D;Conclusion: The specificity and sensitivity of the method of LC early diagnostics and prognosis based on the methylation of&#x0D;blood mononuclear cells (detection of methylation of CG islets associated with the ICAM5, mir138, SYNE1, and KLK4 genes in&#x0D;PBMC) are enough to use it in screening for LC.

Early diagnostic of lung cancer based on methylation of mononuclear cell fraction: Method development