Clinical Validation of a miRNA Blood Test to Identify High-Risk Individuals Eligible for Low-Dose Computed Tomography Screening for Lung Cancer Early Detection.

摘要

The overall objective of this project is to validate whether a lung cancer diagnostic blood test that is based on the detection of a signature of 34 circulating miRNAs (miR-Test) can be used to identify individuals who require further investigation by LDCT screening. The project requires the use of serum samples obtained from at-risk subjects (heavy smokers with defined characteristics) undergoing LDCT screening. Such samples can be classified into two risk classes (Bach-high, and Bach-low), as determined by a risk model developed at IEO. Under separate funding, samples from Bach-high subjects are being analyzed using the miR-Test. The DoD-funded project aims to improve the clinical applicability of the miR-Test blood test by analyzing ~1000 serum samples of Bach-low individuals. A parallel study of 1000 individuals undergoing LDCT screening at the Mount Sinai School of Medicine (MSSM) in New York will provide validation of the miR-Test in an independent, non-Italian cohort of at-risk individuals to assess its applicability internationally. At 12 months, work is in the early phases of profiling the miRNA signatures of the collected serum samples.