Evaluation of the Clinical Utility of Circulating Biomarkers in Advanced Thyroid Carcinomas
IRCCS Azienda Ospedaliero-Universitaria di Bologna
10 participants
Dec 15, 2022
OBSERVATIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria6
- 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,
- Availability of biomolecular profiling performed by multigenic NGS panel on tumor tissue,
- Measurable disease by conventional imaging adopted in clinical practice (total body CT with mdc, CT-PET with FDG or F-DOPA).
Exclusion Criteria2
- Patients already receiving previous lines of systemic therapy,
- Patients not eligible for systemic therapy.
Interventions
For 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
Locations(1)
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NCT06863805