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Modena, Italy

Diazzi C.,University of Modena and Reggio Emilia | Madeo B.,University of Modena and Reggio Emilia | Taliani E.,University of Modena and Reggio Emilia | Zirilli L.,University of Modena and Reggio Emilia | And 7 more authors.
Endocrine Practice | Year: 2013

Objectives: The diagnostic value of calcitonin measurement in fine-needle aspiration biopsy (FNAB) wash-out fluid (Ct-FNAB) for medullary thyroid cancer (MTC) remains to be determined. This prospective study aimed to assess the diagnostic value of Ct-FNAB in thyroid nodules in comparison with basal serum calcitonin (Ct), pentagastrin-stimulated Ct (Pg-sCt), and cytology.Methods: Among patients with goiter addressed with US-FNAB who had an initial clinical suggestion for thyroidectomy, 27 patients with thyroid nodule/s (n = 60) and normal, borderline, or increased Ct fulfilled the criteria for thyroidectomy. All 27 patients (enrolled according to exclusion/inclusion criteria) underwent ultrasonography (US), Ct, Pg-sCt, US-assisted FNAB of each patient's nodule for both cytology, and Ct-FNAB before thyroidectomy.Results: Ct-FNAB always resulted in >1,000 pg/mL in MTC nodules at histology. For values between 36 and 1,000 pg/mL, MTCs and nodular or micronodular C-cell hyperplasia (CCH) results overlapped. Most of the nodules without MTC and/or CCH had Ct- FNABâ‰17 pg/mL. Ct-FNAB diagnostic power was superior to and similar to other diagnostic procedures (Ct, Pg-sCt, and cytology) in identifying both MTC and CCH, and MTC alone, respectively.Conclusion: The diagnostic power of Ct-FNAB is valuable compared with other routine procedures. Ct-FNAB is highly reliable for the early detection and accurate localization of MTC in thyroid nodules, but it does not differentiate between MTC and CCH. Ct-FNAB is an extremely valuable diagnostic tool, especially considering that other diagnostic procedures do not provide a definitive diagnosis, and it can be included in the clinical work-up of thyroid nodules when MTC is suspected. © 2013 AACE.

Papi G.,Catholic University of Rome | Rossi G.,University of Modena and Reggio Emilia | Corsello S.M.,Catholic University of Rome | Corrado S.,University of Modena and Reggio Emilia | And 3 more authors.
European Journal of Endocrinology | Year: 2010

Objective: The isthmus represents a peculiar, as yet partially unexplored, thyroid gland area. Aim of the study: To assess i) the prevalence and clinico-pathological features of solitary thyroid isthmic nodules (STIN); ii) the frequency of medullary thyroid carcinoma (MTC) arising from the isthmus; and iii) the C-cell distribution in the isthmus of patients with MTC and benign nodular thyroid disease (NTD). Subjects and methods: Patients referred from 2006 to 2008 for STIN were prospectively recruited, and underwent serum calcitonin (Ct) measurement and fine needle aspiration cytology (FNAC). MTCs diagnosed from 1993 to 2005 were retrospectively searched. Immunohistochemistry was performed using anti-Ct antibodies on lateral lobes and isthmi of 50 benign NTD and 50 MTC cases. Results: From 1993 to 2005, 150 patients underwent surgery for MTC. All patients had the neoplasm located in lateral thyroid lobes, none in the isthmus. In the 3 years following, 192 STIN patients (40 (21%) males, 152 (79%) females; mean age: 46.2±7.1 years; 6.4% of NTD subjects) were recruited. All had normal Ct concentrations. FNAC was malignant or suspicious for malignancy in 14 (7.3%) patients. Histology found malignancy in 17 (9%) cases, MTC in none. C cells were disclosed in lateral thyroid lobes of 100% MTC and 77% benign NTD patients; isthmi were free of C cells in either group. Conclusions: STINs are significantly less likely to be MTC in patients presenting with sporadic disease. Therefore, Ct screening is not warranted in these subjects. Nonetheless, STINs are more likely to be neoplastic and deserve equal attention as those of the lateral lobes. © 2010 European Society of Endocrinology.

Iudicello A.,Azienda USL of Modena | Alberghini L.,Azienda USL of Bologna | Benini G.,Azienda USL of Bologna | Mosconi P.,Istituto di Ricerche Farmacologiche Mario Negri
Trials | Year: 2016

Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programme (EAP). The regulations regarding EAPs is not the same all over the world. For example, the recommendation of the European Medicines Agency (EMA) in EU countries also includes within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment. Nevertheless, the patients treated in a clinical trial could have the option of continuing treatment for an extended period in an Open-label Extension study, aimed to generate long-term data on efficacy, safety, tolerability and administration. The aims of this paper - based on the difficulties and incoherence encountered by an Italian Ethic Committee (EC) during the authorisation process of EAPs - are: understanding the origin of this misclassification by analysing differences and similarities among USA, European and Italian regulations concerning EAPs; and showing difficulties in classifying international study protocols as a consequence of the lack of harmonisation of definitions. We performed a critical review of the current USA, European and Italian regulations and we analysed some practical cases by retrieving protocols from Clinicaltrials.gov and the Italian Clinical Trials Registry (OsSC) containing in the title the keywords 'Expanded Access Programme', "'Expanded Access', 'Open-label Extension study' or 'Early Access'. We observed that the Food and Drug Administration ( FDA) definition of EAP is very clear while the EMA definition is similar to that of an Open-label Extension study. This lack of a clear definition generates misclassification and it is possible to find an EAP with an efficacy or safety endpoint; or an EAP managed as a clinical trial; or an EAP classified in Clinical Trials Registries as a phase II, III or IV clinical trial. The internationalisation of the studies requires a harmonisation on a global level of legislation and definitions to eliminate misclassification of protocols. For this reason, the authors suggest that: a) the EMA definition should be harmonised with the FDA definition of EAPs, b) European regulation, even if optional, should be adopted in a compulsory way by national regulations. Moreover, separate registries for both EAPs and clinical trials should be organised. © 2016 Iudicello et al.

Muzza M.,Endocrine Unit | Muzza M.,University of Milan | Colombo C.,Endocrine Unit | Colombo C.,University of Milan | And 21 more authors.
Molecular and Cellular Endocrinology | Year: 2015

Telomerase-reverse-transcriptase (TERT) promoter mutations have been recently described in tumors. In the present large series, TERT mutations were found in 12% of papillary thyroid cancers (PTCs) and in 14% of follicular thyroid cancers (FTCs), and were found to significantly correlate with older age at diagnosis and poorer outcome. Interestingly, the prognostic value of TERT mutations resulted to be significantly stronger than that of BRAFV600E. Moreover, the outcome was not different among tumors with isolated TERT mutation and those with coexistent mutations (TERT/BRAF in PTCs or TERT/RAS in FTCs). TERT rs2853669 polymorphism was found in 44.4% of tumors. At WB, TERT was significantly more expressed in tumors than in normal samples, being the highest levels of expression recorded in TERT mutated cases. At IHC, in tumors and in metastatic lymph-nodes TERT staining was significantly higher in the cytoplasm than in the nucleus, whereas in normal tissue the degree of staining did not differ in the two cellular compartments.In conclusion, TERT mutations were shown to strongly correlate with a poorer outcome in differentiated thyroid tumors, and neither BRAF nor RAS mutation were found to confer an additional effect in the disease persistence. TERT protein was found to be more expressed in neoplastic than in normal tissues, and to display a different cellular localization, suggesting that it could contribute to thyroid cancer progression by mechanisms taking place in the cytoplasm. © 2014.

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