Management of Indeterminate Thyroid Nodules Across Different World Regions
1 other identifier
observational
10,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2023
CompletedFirst Submitted
Initial submission to the registry
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2023
CompletedMay 9, 2023
May 1, 2023
3 months
May 1, 2023
May 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (5)
South East Asian Region (SEAR)
Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR
Americas Region (AMR)
Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR
Eastern Mediterranean Region (EMR)
Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR
the Europe Region (EUR)
Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR
Western Pacific Region (WPR)
Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR
Interventions
Total thyroidectomy or lobectomy
Eligibility Criteria
We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide
You may qualify if:
- Patients with Bethesda III / Bethesda IV thyroid nodules
You may not qualify if:
- Patients with preoperative diagnosis of lymph node metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Cagliari
Cagliari, CA, 09100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 1, 2023
First Posted
May 9, 2023
Study Start
April 25, 2023
Primary Completion
July 30, 2023
Study Completion
September 15, 2023
Last Updated
May 9, 2023
Record last verified: 2023-05