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

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ClinicalTrials.gov Identifier: NCT05428371
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : June 23, 2022
Sponsor:
Collaborators:
Prof. Pietro Giorgio Calò
Dott. Gian Luigi Canu
Information provided by (Responsible Party):
Fabio Medas, University of Cagliari

Study Description
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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
Thyroid Nodule Thyroid Cancer Diagnostic Test: Multiomic analyses of blood and surgical specimens

Study Design
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Study Type : Observational
Estimated 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
Estimated Study Start Date : January 1, 2023
Estimated Primary Completion Date : May 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
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Group/Cohort 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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05428371


Locations
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Italy
AOU Cagliari
Cagliari, CA, Italy, 09100
Sponsors and Collaborators
University of Cagliari
Prof. Pietro Giorgio Calò
Dott. Gian Luigi Canu
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Fabio Medas, Associate Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT05428371    
Other Study ID Numbers: THYOMICS
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be available under reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fabio Medas, University of Cagliari:
Thyroid carcinoma
Indeterminate thyroid nodule
Genomics
Proteomics
Metabolomics
Additional relevant MeSH terms:
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Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms