The study is aimed at all adult patients diagnosed with advanced thyroid carcinomas and well-differentiated thyroid carcinomas (DTC) iodine-refractory, well-differentiated iodine-refractory thyroid (RAI-R DTC) metastatic carcinomas that are candidates for systemic therapy. By simple blood sampling and analysis on peripheral blood of circulating DNA (ccf-DNA), circulating RNA (ccf-RNA), and counting and analysis of circulating tumor cells through the use of liquid biopsy, molecular profiling corresponding to those obtained by genomic sequencing on tumor tissue can be arrived at, depending on optimal therapeutic choices
Signed written informed consent,
Adult (≥18 years) male or female patients
Histologic diagnosis of advanced thyroid carcinoma confirmed at centralized review,
well-differentiated thyroid carcinomas, medullary thyroid carcinomas, anaplastic thyroid carcinomas, advanced, candidates for initiation of systemic medical therapy,
Patients already receiving previous lines of systemic therapy,
Patients not eligible for systemic therapy.
adult patients (≥ 18 years) with metastatic RAI-R DTC who are candidates for systemic therapy, as per clinical practice
Cohort
Prospective
4 EDTA tubes of peripheral blood for Multigene analysis on ccf-DNA and ccf-RNA
Diagnostic testFor each patient enrolled in the present study, 4 EDTA tubes of peripheral blood will be collected to be used to obtain molecular profiling during scheduled laboratory controls as per normal clinical practice according to the following time schedule: * T0 = basal collection before initiation of systemic treatment; * T1 = sampling at 1 month after the start of systemic treatment; * T2 = sampling at 3 months (+/- 1 month) after the start of systemic treatment at the first instrumental re-evaluation of disease; * T3 = sampling at 6 months (+/- 1 month) from the start of systemic treatment at the time of instrumental disease reassessment; * T4 = sampling at the time of evidence of instrumental disease progression within 24 months of treatment initiation. The following analyses will be conducted on the samples thus collected: * multigenic analysis on ccf-DNA and ccf-RNA at baseline, i.e., before the initiation of systemic treatment; * isolation, counting and analysis of CTCs at baseline vi
Genomic alterations
Presence of BRAF mutations, RAS mutations, RET mutations, rearrangements of NTRK, RET, ALK, etc. in ccf-DNA, ccf-RNA and Circulating Tumour Cells (CTCs)
Early metabolic response rate
Early metabolic response rate evaluated by FDG-PET
Overall response rate (ORR)
Rate of clinical response
Progression-free survival (PFS)
Progression-free survival (PFS) assessed throughout the study
Tumour load
Calculated as sum of diameters (SOD) of measurable disease according to RECIST v.1.1 criteria
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