Management of Indeterminate Thyroid Nodules Across Different World Regions

NCT ID: NCT05851404

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Indeterminate Thyroid Nodules

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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South East Asian Region (SEAR)

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR

Thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy or lobectomy

Americas Region (AMR)

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR

Thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy or lobectomy

Eastern Mediterranean Region (EMR)

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR

Thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy or lobectomy

the Europe Region (EUR)

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR

Thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy or lobectomy

Western Pacific Region (WPR)

Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR

Thyroidectomy

Intervention Type PROCEDURE

Total thyroidectomy or lobectomy

Interventions

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Thyroidectomy

Total thyroidectomy or lobectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion Criteria

* Patients with preoperative diagnosis of lymph node metastases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Fabio Medas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOU Cagliari

Cagliari, CA, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Fabio Medas, MD

Role: primary

+393206836288

Other Identifiers

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UNICA-MEDAS-23-01

Identifier Type: -

Identifier Source: org_study_id

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