Management of Indeterminate Thyroid Nodules Across Different World Regions

Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study

Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification[2]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.

We aim to evaluate different approaches to indeterminate nodules across different countries in the world.

Study Overview

• Status: Recruiting
• Conditions: Indeterminate Thyroid Nodules
• Intervention / Treatment: Procedure: Thyroidectomy

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• Italy
  • CA
    • Cagliari, CA, Italy, 09100
      • Recruiting
      • AOU Cagliari
      • Contact: Fabio Medas, MD; Phone Number: +393206836288; Email: fabiomedas@unica.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide

Description

Inclusion Criteria:

• Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria:

• Patients with preoperative diagnosis of lymph node metastases

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
South East Asian Region (SEAR); Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR	Procedure: Thyroidectomy; Total thyroidectomy or lobectomy
Americas Region (AMR); Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR	Procedure: Thyroidectomy; Total thyroidectomy or lobectomy
Eastern Mediterranean Region (EMR); Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR	Procedure: Thyroidectomy; Total thyroidectomy or lobectomy
the Europe Region (EUR); Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR	Procedure: Thyroidectomy; Total thyroidectomy or lobectomy
Western Pacific Region (WPR); Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR	Procedure: Thyroidectomy; Total thyroidectomy or lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of malignancy	Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules	36 months
Surgical approach to indeterminate thyroid nodules	Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules	36 months

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): September 15, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Thyroid carcinoma; Indeterminate thyroid nodule
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: UNICA-MEDAS-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No