NCT06653257

Active Surveillance Program in Thyroid Nodules

Not yet recruiting Last updated 29 October 2024

What this trial tests

trial testing Active surveillance in Thyroid Nodule in 300 participants. Not yet recruiting.

Timeline

1 November 2024

Primary endpoint
1 February 2026

1 July 2026

Quick facts

Lead sponsor	Centro de Excelencia en Enfermedades de Cabeza y Cuello
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	300
Start date	1 November 2024
Primary completion	1 February 2026
Estimated completion	1 July 2026
Sites	4 locations across Colombia

Drugs / interventions tested

• Active surveillance

Conditions studied

• Thyroid Nodule — all drugs for Thyroid Nodule →

Sponsor

Centro de Excelencia en Enfermedades de Cabeza y Cuello — full company profile →

Who can join

18 and older, any sex, with Thyroid Nodule. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Overview This study focuses on thyroid nodules, specifically the Bethesda IV-VI categories, which have uncertain or suspicious malignancy. The idea is to observe and monitor these nodules instead of opting for immediate surgery, a practice known as active surveillance. The main goal of active surveillance is to avoid unnecessary surgeries, which can lead to complications like nerve damage or hypoparathyroidism.

Problem and Objectives Thyroid nodules in these Bethesda categories can be cancerous, but not all require immediate removal. Active surveillance tracks nodule growth and other changes using regular ultrasounds and clinical checkups. This approach is gaining popularity, especially in Japan, Europe, and the U.S., but there's still a need for more data, particularly in Latin America.

The primary objectives of the study are:

General: To describe the clinical and imaging characteristics of patients with Bethesda IV-VI nodules under active surveillance.

Specific: To measure surgery rates, reasons for surgery, and how long patients can avoid surgery.

Methodology This study is a multicenter historical cohort study, which will look at patients treated from 2019 to 2023 in different hospitals. Patients included in the study are those with Bethesda IV-VI thyroid nodules, who are over 18 and have been managed without immediate thyroid surgery. Data will be collected from medical records and imaging reports, and patients will be followed up to document any changes in their nodules, including growth or metastasis.

Expected Impact The study aims to determine whether active surveillance can safely delay or avoid surgery for selected patients. It could have a significant impact on clinical decision-making, improving patient outcomes and reducing unnecessary surgeries, especially within the Colombian healthcare system. If successful, this approach could reduce costs and improve the quality of life for patients with thyroid nodules.

Ethical Considerations The study will follow ethical guidelines, ensuring patient confidentiality and classifying the research as "no-risk," meaning it involves minimal risk to the participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.