Purpose: <br />To identify tumor-derived exosomal biomarkers that are able to discriminate between adenocarcinoma (AC) and squamous cell carcinoma (SCC) as a non-invasive method in the early diagnosis of non-small-cell lung cancer (NSCLC). <br /><br />Experimental Design: <br />Tumor-derived exosomes from the plasma of early stage NSCLC patients were isolated. Exosomal miRNA profiling of 46 stage I NSCLC patients and 42 healthy individuals was performed using miRNA-seq to identify and validate AC- and SCC-specific miRNAs. The diagnostic accuracy of select miRNAs was tested further with an additional 60 individuals.<br /><br />Results: <br />There were 11 and 6 miRNAs expressed at remarkably higher levels, 13 and 8 miRNAs expressed at lower levels in AC and SCC patients, respectively, compared to healthy volunteers. Distinct AC- and SCC-specific exosomal miRNAs were validated. The reliability of miRNA-seq data was verified with several demonstrated diagnostic potential miRNAs for NSCLC and other carcinomas, as reported in previous studies, such as let-7, miR-21, miR-24 and miR-486. The results indicated that miR-181-5p, miR-30a-3p, miR-30e-3p and miR-361-5p were AC-specific, and miR-10b-5p, miR-15b-5p and miR-320b were SCC-specific. The diagnostic accuracy of three combination miRNA panels was evaluated using an AUC value of 0.899, 0.936, and 0.911 for detecting NSCLC, AC and SCC, respectively.<br /><br />Conclusions:<br /> <p> Tumor-derived exosomal miRNAs, AC-specific miR-181-5p, miR-30a-3p, miR-30e-3p and miR-361-5p, and SCC-specific miR-10b-5p, miR-15b-5p and miR-320b, were observed by next-generation sequencing, and their diagnostic accuracy were verified. These miRNAs may be promising and effective candidates in the development of highly sensitive, non-invasive biomarkers for early NSCLC diagnosis.
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