Biomild NIH
Sottotitolo
Identifying non-coding RNAs for early detection and prevention of lung cancer.
Disegno Studio
Retrospettivo
Centro
Multicentrico
Anno di inizio
2013
Ruolo di Ugo Pastorino
Co-Principal Investigator
Stato
Ongoing
Funding Agencies
NIH
Sinossi
We recently published a large clinical validation study where the diagnostic performance of the plasma miRNA classifier (miRNA signature classifier MSC) was retrospectively evaluated in samples prospectively collected from 930 smoker subjects within the randomized Multicentre Italian Lung Detection (MILD) clinical trial.
MSC showed a diagnostic sensitivity of 87%, specificity of 81%, NPV of 99% and the diagnostic performance of MSC as a predictor of lung cancer development up to 24 months before the tumor became visible by LDCT scans was confirmed by the time dependency analysis. Moreover, when used together with LDCT, false positive rate was only 4% which compares very favorably with 96.4% in LDCT scans alone, the current standard in lung cancer detection.
Furthermore, the MSC risk groups were associated with significantly different survival at 3 years for the entire cohort of 939 subjects (100%, 97% and 77% for Low, Intermediate and High MSC respectively). These findings indicate that plasma miRNAs identify both malignancy and aggressiveness of the tumor (see Sozzi G. JCO 2014).
Aims of the project: To definitely prove the clinical utility of plasma miRNA biomarkers and their power in the prediction and in the classification of the disease, we started a large scale prospective study including thousands individuals (
www.biomild.org).
Pubblicazioni
