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

June 16, 2022 updated by: Fabio Medas, University of Cagliari

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • CA
      • Cagliari, CA, Italy, 09100
        • AOU Cagliari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
50 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

Prof. Pietro Giorgio Calò
Dott. Gian Luigi Canu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

May 31, 2027

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THYOMICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Individual participant data will be available under reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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