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

Sponsor

University of Cagliari (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05428371

Collaborator

Prof. Pietro Giorgio Calò (Other), Dott. Gian Luigi Canu (Other)

256

Enrollment

Location

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Nodule Thyroid Cancer	Diagnostic Test: Multiomic analyses of blood and surgical specimens

Study Design

Study Type:

Observational

Anticipated Enrollment :

256 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

May 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Thyroid carcinoma Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma	Diagnostic Test: Multiomic analyses of blood and surgical specimens 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)
Follicular adenoma Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma	Diagnostic Test: Multiomic analyses of blood and surgical specimens 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)

Arm

Intervention/Treatment

Thyroid carcinoma

Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma

Diagnostic Test: Multiomic analyses of blood and surgical specimens

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)

Follicular adenoma

Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma

Diagnostic Test: Multiomic analyses of blood and surgical specimens

Outcome Measures

Primary Outcome Measures

Identification of biomarkers of thyroid carcinoma [50 months]
Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma

Secondary Outcome Measures

Elaboration of diagnostic algorithm [60 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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