An interventional study of Active surveillance (6, 12, 18, 24, 36, 48, 60 months) in Thyroid Cancer and Thyroid Nodule, sponsored by Christian Grønhøj Larsen. Recruiting at 1 site in Denmark. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Christian Grønhøj Larsen · Not applicable, Interventional, and Treatment
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's planned enrollment of 165 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →This is the only study on the registry with Christian Grønhøj Larsen as lead sponsor.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active surveillance with ultrasound and clinical follow-up in a 5 year period
Other: Active surveillance (6, 12, 18, 24, 36, 48, 60 months)
Active Surveillance og thyroid nodules with Bethesda IV cytology instead of surgery (diagnostic hemithyroidectomy).
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
Plan to share: No
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