RecruitingNot ApplicableNCT07370675

Active Surveillance for Bethesda IV Thyroid Nodules

Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol


Sponsor

Christian Grønhøj Larsen

Enrollment

165 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The traditional surgical approach for Bethesda IV thyroid nodules burdens healthcare systems and patients with costs, perioperative morbidity, and potential long-term consequences of hemithyroidectomy, including hypothyroidism (requiring lifelong thyroid hormone replacement), nerve damage, infection, voice discomfort and postoperative bleeding. Moreover, patient-reported anxiety and reduced quality of life often follow surgery, regardless of benign final pathology. Conversely, surveillance strategies that include periodic ultrasound assessment, clinical examination, and patient education may reduce overtreatment, preserve thyroid function, and optimize resource utilization. This prospective cohort protocol seeks to address these gaps by systematically evaluating the safety, feasibility, patient experience, and clinicopathologic predictors of progression for Bethesda IV nodules \<2 cm managed with active surveillance. Our hypothesis is: In patients with thyroid nodules smaller than 2 cm and cytology consistent with Bethesda IV, active surveillance is a safe and feasible alternative to immediate surgery. We hypothesize that only a minority of patients will demonstrate clinically significant tumor progression or require surgical intervention within five years, and that prospective surveillance can prevent unnecessary thyroid operations without compromising patient safety or long-term outcomes. The primary aim of this study is to determine the proportion of patients with Bethesda IV thyroid nodules \<2 cm who undergo surgical intervention or experience disease progression over a 1-, 2- and 5 year AS period.


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether people with a certain type of thyroid nodule (classified as Bethesda IV, which is suspicious but not confirmed cancer) can safely be monitored with regular scans instead of immediately having surgery. **You may be eligible if...** - You are 30 years of age or older - You have a single thyroid nodule classified as Bethesda IV (follicular neoplasm or suspicious for follicular neoplasm) - The nodule is smaller than 2 cm - The nodule appears as EU-TIRADS 3 or 4 on ultrasound (low to intermediate suspicion) **You may NOT be eligible if...** - Your nodule is classified as EU-TIRADS 5 on ultrasound (high suspicion) - There are signs the cancer may have spread, such as suspicious lymph nodes, capsule invasion, or irregular shape - The nodule is in a high-risk location near important structures - You have previously had thyroid surgery - You have high calcium levels combined with elevated PTH (a parathyroid condition) - You are pregnant - Your calcitonin level is elevated above normal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERActive surveillance (6, 12, 18, 24, 36, 48, 60 months)

Active Surveillance og thyroid nodules with Bethesda IV cytology instead of surgery (diagnostic hemithyroidectomy).


Locations(1)

Department of Otolaryngology, Head and Neck SurgeryRigshospitalet

Copenhagen, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07370675


Related Trials