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

Not yet recruiting

• Conditions: Thyroid Nodule; Thyroid Cancer
• Interventions: Diagnostic Test: Multiomic analyses of blood and surgical specimens

• Registration Number: NCT05428371
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23
• Study Start: 2023-01-01
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follicular adenoma	Multiomic analyses of blood and surgical specimens	Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma
Thyroid carcinoma	Multiomic analyses of blood and surgical specimens	Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma

Primary Outcome Measures

Name	Time	Method
Identification of biomarkers of thyroid carcinoma	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

Name	Time	Method
Elaboration of diagnostic algorithm	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

Trial Locations

Locations (1)

AOU Cagliari; 🇮🇹 Cagliari, CA, Italy