Management of Indeterminate Thyroid Nodules Across Different World Regions

Indeterminate Thyroid Nodules Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851404
• Other study ID #: UNICA-MEDAS-23-01
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2023
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: September 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria:

• Patients with preoperative diagnosis of lymph node metastases

Related Conditions & MeSH terms

• Indeterminate Thyroid Nodules
• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• Thyroidectomy
Total thyroidectomy or lobectomy

Locations

Country	Name	City	State
Italy	AOU Cagliari	Cagliari	CA

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of malignancy	Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules	36 months
Primary	Surgical approach to indeterminate thyroid nodules	Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules	36 months