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

N/ANot Yet RecruitingNCT05428371

University of Cagliari256 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

256

Conditions

Thyroid Nodule Thyroid Cancer

Interventions

Multiomic analyses of blood and surgical specimensDIAGNOSTIC_TEST

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AOU Cagliari

Cagliari, CA, Italy

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

Time frame: 50 months

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

Time frame: 60 months

Data from ClinicalTrials.gov

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