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NCT Number: NCT05428371

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

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.

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Key information

Conditions

Thyroid Nodule Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Cagliari

Cagliari, CA, 09100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiomic analyses of blood and surgical specimens

Diagnostic 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)

Primary outcomes

  1. Identification of biomarkers of thyroid carcinoma

    Time frame: 50 months

    Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma

Secondary outcomes

  1. Elaboration of diagnostic algorithm

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • Dott. Gian Luigi Canu
  • Prof. Pietro Giorgio Calò

Registry information

Official study title

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

Acronym: THYOMICS

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2022
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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