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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05428371

Acronym

THYOMICS

Enrollment

256

Registered

2022-06-23

Start date

2023-01-01

Completion date

2027-12-31

Last updated

2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Thyroid Nodule

Keywords

Thyroid carcinoma, Indeterminate thyroid nodule, Genomics, Proteomics, Metabolomics

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.

Interventions

DIAGNOSTIC_TESTMultiomic 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)

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026