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Trial Title:
Management of Indeterminate Thyroid Nodules Across Different World Regions
NCT ID:
NCT05851404
Condition:
Indeterminate Thyroid Nodules
Conditions: Official terms:
Thyroid Nodule
Thyroid Diseases
Conditions: Keywords:
Indeterminate thyroid nodule
Thyroid carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Thyroidectomy
Description:
Total thyroidectomy or lobectomy
Arm group label:
Americas Region (AMR)
Arm group label:
Eastern Mediterranean Region (EMR)
Arm group label:
South East Asian Region (SEAR)
Arm group label:
Western Pacific Region (WPR)
Arm group label:
the Europe Region (EUR)
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.
Criteria for eligibility:
Study pop:
We aim to investigate different approaches to indeterminate thyroid nodules across
different countries worldwide
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with Bethesda III / Bethesda IV thyroid nodules
Exclusion Criteria:
- Patients with preoperative diagnosis of lymph node metastases
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AOU Cagliari
Address:
City:
Cagliari
Zip:
09100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Fabio Medas, MD
Phone:
+393206836288
Email:
fabiomedas@unica.it
Start date:
April 25, 2023
Completion date:
September 15, 2023
Lead sponsor:
Agency:
University of Cagliari
Agency class:
Other
Source:
University of Cagliari
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851404