Management of Indeterminate Thyroid Nodules Across Different World Regions

Sponsor

University of Cagliari (Other)

Overall Status

Recruiting

CT.gov ID

NCT05851404

Collaborator

(none)

10,000

Enrollment

Location

4.7

Anticipated Duration (Months)

2128.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Indeterminate Thyroid Nodules	Procedure: Thyroidectomy

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 25, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
South East Asian Region (SEAR) Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR	Procedure: Thyroidectomy Total thyroidectomy or lobectomy
Americas Region (AMR) Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR	Procedure: Thyroidectomy Total thyroidectomy or lobectomy
Eastern Mediterranean Region (EMR) Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR	Procedure: Thyroidectomy Total thyroidectomy or lobectomy
the Europe Region (EUR) Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR	Procedure: Thyroidectomy Total thyroidectomy or lobectomy
Western Pacific Region (WPR) Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR	Procedure: Thyroidectomy Total thyroidectomy or lobectomy

Outcome Measures

Primary Outcome Measures

Rate of malignancy [36 months]
Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Surgical approach to indeterminate thyroid nodules [36 months]
Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria:

Patients with preoperative diagnosis of lymph node metastases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Cagliari	Cagliari	CA	Italy	09100

Sponsors and Collaborators

University of Cagliari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fabio Medas, Associate Professor, University of Cagliari

ClinicalTrials.gov Identifier:

NCT05851404

Other Study ID Numbers:

UNICA-MEDAS-23-01

First Posted:

May 9, 2023

Last Update Posted:

May 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fabio Medas, Associate Professor, University of Cagliari

Indeterminate thyroid nodule

Thyroid carcinoma

Additional relevant MeSH terms:

Thyroid Nodule

Thyroid Diseases

Study Results

No Results Posted as of May 9, 2023