NCT07370675Recruiting
Active Surveillance for Bethesda IV Thyroid Nodules
Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 16 Jan 2026
- Primary completion date
- 16 Jan 2033
- Lead sponsor
- Christian Grønhøj Larsen
- Diseases
- Thyroid cancer
- NCT number
- NCT07370675
What you commit to
- Study type: Interventional
- Planned participants: 165
- From 16 Jan 2026 to the primary completion date, 16 Jan 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous thyroid surgery OR
Other illness
- suspicion of disseminated disease because of PET-positive lymph nodes; suspect lymph-nodes by US or by CT-scan; or signs of capsular invasion of the tumor, or irregular shape or margins, extrathyroidal growth OR
Lab values
- concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/L and PTH \> 6 pmol/L) OR
Other
- EU-TIRADS 5 in Ultrasound imaging examination.
- tumor placement at a high-risk location (in the thyroid capsule with extracapsular extension toward vessels, RLN, or the trachea) OR
- if the patient is pregnant OR
- If the patient is unable to give informed consent. OR
- If calcitonin is elevated above normal level
Who the study is looking for
- age of 30 years or older AND
- a single nodule with a Follicular neoplasm or suspicious for a follicular neoplasm (category IV in the Bethesda system) AND
- tumor size of less than 2 cm in all dimensions AND
- EU-TIRADS 3 or 4 in Ultrasound imaging examination.
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Otolaryngology, Head and Neck SurgeryRigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.