Management of Indeterminate Thyroid Nodules Across Different World Regions

University of Cagliari

Status: Enrolling

Conditions: Indeterminate Thyroid Nodules

Treatments: Procedure: Thyroidectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05851404

UNICA-MEDAS-23-01

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion criteria

• Patients with preoperative diagnosis of lymph node metastases

Trial design

10,000 participants in 5 patient groups

South East Asian Region (SEAR)

Description:

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR

Treatment:

Procedure: Thyroidectomy

Americas Region (AMR)

Description:

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR

Treatment:

Procedure: Thyroidectomy

Eastern Mediterranean Region (EMR)

Description:

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR

Treatment:

Procedure: Thyroidectomy

the Europe Region (EUR)

Description:

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR

Treatment:

Procedure: Thyroidectomy

Western Pacific Region (WPR)

Description:

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR

Treatment:

Procedure: Thyroidectomy