About this trial
Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)
Disqualifiers
Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
Patients with distant metastases
Trial population
We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)
Trial design
Case-control
Prospective
Treatments tested in this trial
Multiomic analyses of blood and surgical specimens
Diagnostic testThe following items will be evaluated: * cell free dna length and integrity * presence or absence of SNPs in cfDNA and in DNA extracted from surgical samples * qualitative and quantitative evaluation of serum and surgical specimens proteome (proteomics)
Treatment groups
Trial outcomes
Primary outcomes
Identification of biomarkers of thyroid carcinoma
Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma
Secondary outcomes
Elaboration of diagnostic algorithm
Elanoration of diagnostic algorithm predictive of thyroid carcinoma through integration of clinical, ultrasonographic and multiomic variables able to predict che condition of thyroid cancer in patients with indeterminate thryoid nodules
Sponsors and contacts
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University of Cagliari
Lead sponsor
Prof. Pietro Giorgio Calò
Collaborator
Dott. Gian Luigi Canu
Collaborator
This trial is not recruiting at the moment. You can still explore other options: