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Study identifier: NCT07370675 Synced from ClinicalTrials.gov · August 03, 2026
● Recruiting

Active Surveillance for Bethesda IV Thyroid Nodules

Condition: Thyroid Cancer · Thyroid Nodule  ·  Sponsor: Christian Grønhøj Larsen

PhaseNA
Planned participants165
Who can joinAll sexes, 30 Years to no upper limit
Healthy volunteersNo

About this study

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 Bethe…

This description comes directly from the study's public registry record.

Talk to the study team

Nicoline Thorup, MD, PhD Fellow  ·  0045 45356863  ·  nicoline.thorup@regionh.dk

Always discuss trial participation with your own doctor first.

Locations (1)

Department of Otolaryngology, Head and Neck SurgeryRigshospitaletCopenhagen, DenmarkRecruiting

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