Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features

Study Overview
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Brief Summary
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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.

Official Title
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A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules

Conditions
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Thyroid Nodule, Thyroid Cancer

Intervention / Treatment
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* Diagnostic Test: Multiomic analyses of blood and surgical specimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thyroid carcinoma<br>Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma | Diagnostic Test: Multiomic analyses of blood and surgical specimens<br>* The 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)<br>|
| Follicular adenoma<br>Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma | Diagnostic Test: Multiomic analyses of blood and surgical specimens<br>* The 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 50 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid carcinoma, Indeterminate thyroid nodule, Genomics, Proteomics, Metabolomics