Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiomic analyses of blood and surgical specimens.
- Who it may be relevant to
- Registry conditions: Thyroid Nodule, Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules
Overview
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.
Interventions
- 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)
Primary outcome measures
- Identification of biomarkers of thyroid carcinoma [Time frame: 50 months]
Secondary outcome measures (1)
- Elaboration of diagnostic algorithm [Time frame: 60 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- AOU Cagliari — Cagliari
Identifiers
NCT: NCT05428371 · THYOMICS