Thyroid CancerNCT07370675
Active Surveillance for Bethesda IV Thyroid Nodules
A study testing Active surveillance (6, 12, 18, 24, 36, 48, 60 months) in people with Thyroid Cancer and Thyroid Nodule, run by Christian Grønhøj Larsen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Nodule
- What is being tested?
- Active surveillance (6, 12, 18, 24, 36, 48, 60 months)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jan 2026to 16 Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- EU-TIRADS 5 in Ultrasound imaging examination.
- 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
- tumor placement at a high-risk location (in the thyroid capsule with extracapsular extension toward vessels, RLN, or the trachea) OR
- previous thyroid surgery OR
- concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol/L) OR
- if the patient is pregnant OR
- If the patient is unable to give informed consent. OR
- If calcitonin is elevated above normal level
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Head and Neck SurgeryRigshospitalet
Copenhagen, 2100
Nicoline Thorup, MD, PhD Fellow, 0045 45356863, nicoline.thorup@regionh.dk
About this study
Official title: Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
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.
Read more
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.
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Being tested
- Active surveillance (6, 12, 18, 24, 36, 48, 60 months)
- Medical subject headings
- Thyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Active Surveillance | Experimental | Active surveillance with ultrasound and clinical follow-up in a 5 year period Receives: Other: Active surveillance (6, 12, 18, 24, 36, 48, 60 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who undergo surgical intervention or experience disease progression during active surveillance
Measured: From enrollment in to active surveillance to the end of the follow-up programe at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start16 Jan 2026
- Primary completion16 Jan 2033 (estimated)
- Study completion16 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Grønhøj Larsen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Christian Grønhøj Larsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370675
- Sponsor's protocol ID
- 25047119
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Small Thyroid Nodules With Bethesda IV Cytology: A Prospective Cohort Study Protocol
- ClinicalTrials.gov ID
- NCT07370675
- Acronym / sponsor ID
- 25047119
- Conditions
- Thyroid Cancer, Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Christian Grønhøj LarsenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 16 Jan 2033 (estimated)
- Study completion
- 16 Jan 2033 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | Experimental | Other: Active surveillance (6, 12, 18, 24, 36, 48, 60 months)Active surveillance with ultrasound and clinical follow-up in a 5 year period |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- EU-TIRADS 5 in Ultrasound imaging examination.
- 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
- tumor placement at a high-risk location (in the thyroid capsule with extracapsular extension toward vessels, RLN, or the trachea) OR
- previous thyroid surgery OR
- concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol/L) OR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillance (6, 12, 18, 24, 36, 48, 60 months)Active Surveillance og thyroid nodules with Bethesda IV cytology instead of surgery (diagnostic hemithyroidectomy). | Other | Active Surveillance |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active surveillance (6, 12, 18, 24, 36, 48, 60 months) in people with Thyroid Cancer and Thyroid Nodule, run by Christian Grønhøj Larsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicoline Thorup, MD, PhD Fellow (0045 45356863, nicoline.thorup@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.