Active Surveillance for Bethesda IV Thyroid Nodules

Sponsor
Christian Grønhøj Larsen
Study ID
NCT07370675
Status
Recruiting
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Conditions

  • Thyroid Cancer
  • Thyroid Nodule

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active surveillance (6, 12, 18, 24, 36, 48, 60 months) — OTHER
    Active Surveillance og thyroid nodules with Bethesda IV cytology instead of surgery (diagnostic hemithyroidectomy).

Study Details

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.

Key Dates

First listed
Jan 27, 2026
Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Jan 16, 2033
Completion
Jan 16, 2033

Study Design

Enrollment
165 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active Surveillance
    Active surveillance with ultrasound and clinical follow-up in a 5 year period

Primary Outcome Measure

Number of participants who undergo surgical intervention or experience disease progression during active surveillance [ Time Frame: From enrollment in to active surveillance to the end of the follow-up programe at 5 years ]

Central Contacts

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