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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cagliari

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)

Disqualifiers

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

Trial 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%)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Thyroid carcinoma1 intervention
Group B: Follicular adenoma1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
50 months

Secondary outcomes

1

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

Time frame
60 months

Other outcomes

Sponsors and contacts

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University of Cagliari

Lead sponsor

Prof. Pietro Giorgio Calò

Collaborator

Dott. Gian Luigi Canu

Collaborator

This trial is not recruiting at the moment. You can still explore other options: