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NCT05428371 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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