Summary
Fine needle aspiration cytology (FNAC) is the best procedure for a timely and reliable diagnosis of either a benign or malignant thyroid lesion. However, the management of patients with indeterminate cytology (10-26%) is a frequent clinical and social problem, as this cytological category is associated with a 15 to 30% prevalence of malignancy, forcing most of these patients to diagnostic surgery. However, for the 80% of these patients the surgery is unnecessary as the postoperative histology reveal a benign lesion. The negative social and financial consequences of this approach are relevant in Europe (44000/year thyroidectomy only in Italy) as well as the adverse influences on the quality of life of the patients due to surgical complications and hormone replacement. We will introduce in the market the first clinically validated CE-IVD targeted Next Generation Sequencing diagnostic kit ThyroTrust for the correct diagnosis of thyroid nodules with indeterminate cytology.
Our kit is the first to include a considerable number of variations in 47 genes, 66 types of rearrangements and 8 gene expression level measured at the same time and associated with malignant outcome. This will avoid diagnostic surgery if a risk of malignancy
Our kit is the first to include a considerable number of variations in 47 genes, 66 types of rearrangements and 8 gene expression level measured at the same time and associated with malignant outcome. This will avoid diagnostic surgery if a risk of malignancy
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/711330 |
| Start date: | 01-02-2016 |
| End date: | 31-07-2016 |
| Total budget - Public funding: | 71 429,00 Euro - 50 000,00 Euro |
Cordis data
Original description
Fine needle aspiration cytology (FNAC) is the best procedure for a timely and reliable diagnosis of either a benign or malignant thyroid lesion. However, the management of patients with indeterminate cytology (10-26%) is a frequent clinical and social problem, as this cytological category is associated with a 15 to 30% prevalence of malignancy, forcing most of these patients to diagnostic surgery. However, for the 80% of these patients the surgery is unnecessary as the postoperative histology reveal a benign lesion. The negative social and financial consequences of this approach are relevant in Europe (44000/year thyroidectomy only in Italy) as well as the adverse influences on the quality of life of the patients due to surgical complications and hormone replacement. We will introduce in the market the first clinically validated CE-IVD targeted Next Generation Sequencing diagnostic kit ThyroTrust for the correct diagnosis of thyroid nodules with indeterminate cytology.Our kit is the first to include a considerable number of variations in 47 genes, 66 types of rearrangements and 8 gene expression level measured at the same time and associated with malignant outcome. This will avoid diagnostic surgery if a risk of malignancy
Status
CLOSEDCall topic
PHC-12-2015-1Update Date
26-10-2022
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