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Management of Indeterminate Thyroid Nodules Across Different World Regions

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05851404
Enrollment
10000
Registered
2023-05-09
Start date
2023-04-25
Completion date
2023-09-15
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indeterminate Thyroid Nodules

Keywords

Indeterminate thyroid nodule, Thyroid carcinoma

Brief 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.

Interventions

PROCEDUREThyroidectomy

Total thyroidectomy or lobectomy

Sponsors

University of Cagliari
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion criteria

* Patients with preoperative diagnosis of lymph node metastases

Design outcomes

Primary

MeasureTime frameDescription
Rate of malignancy36 monthsNumber of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Surgical approach to indeterminate thyroid nodules36 monthsNumber of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026