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

Thyroid Cancer Clinical Trial

— THYOMICS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05428371
• Other study ID #: THYOMICS
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2022
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

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)

Locations

Country	Name	City	State
Italy	AOU Cagliari	Cagliari	CA

Sponsors (3)

Lead Sponsor	Collaborator
University of Cagliari	Dott. Gian Luigi Canu, Prof. Pietro Giorgio Calò

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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