Ricerc@Sapienza

The prevalence of thyroid nodules in the general population is high, but only about 5% are malignant lesions. Cytology is usually appropriate to rule out malignancy in sonographically suspicious nodules, but in many cases reports are indeterminate. Molecular testing is a more recent approach to rule out malignancy and guide subsequent management.
We recently reported the development and analytical validation of a novel dual-component molecular assay as an ancillary method to improve clinical decision-making in patients with indeterminate thyroid nodule cytology. The assay involves next-generation sequencing (NGS) based detection of mutations in 23 thyroid cancer related genes and digital polymerase chain reaction (dPCR) evaluation of the expression levels of a microRNA strongly associated with thyroid cancer. The assay is planned as a ruling out test and preliminary results showed a negative predictive value comparable to a negative diagnostic cytology.
Aim of this proposal is to describe the performance of the novel dual molecular assay in a real-world cohort of cytologically indeterminate thyroid nodules and to evaluate whether the use of this test in real-world clinical routine can reduce the rates of surgeries for indeterminate thyroid nodules.