作者: Erik K. Alexander , Giulia C. Kennedy , Zubair W. Baloch , Edmund S. Cibas , Darya Chudova
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摘要: BACKGROUND Approximately 15 to 30% of thyroid nodules evaluated by means fine-needle aspiration are not clearly benign or malignant. Patients with cytologically indeterminate often referred for diagnostic surgery, though most these prove be benign. A novel test that measures the expression 167 genes has shown promise in improving preoperative risk assessment. METHODS We performed a 19-month, prospective, multicenter validation study involving 49 clinical sites, 3789 patients, and 4812 aspirates from 1 cm larger required evaluation. obtained 577 aspirates, 413 which had corresponding histopathological specimens excised lesions. Results central, blinded review served as reference standard. After inclusion criteria were met, gene-expression classifier was used 265 this analysis, its performance assessed. RESULTS Of nodules, 85 The correctly identified 78 suspicious (92% sensitivity; 95% confidence interval [CI], 84 97), specificity 52% (95% CI, 44 59). negative predictive values “atypia (or follicular lesion) undetermined significance,” “follicular neoplasm lesion neoplasm,” “suspicious cytologic findings” 95%, 94%, 85%, respectively. Analysis 7 false results revealed 6 paucity cells, suggesting insufficient sampling nodule. CONCLUSIONS These data suggest consideration more conservative approach patients on according results. (Funded Veracyte.)