Could watching and waiting beat the needle for thyroid nodules?
NCT ID NCT06220656
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing whether active monitoring (regular ultrasounds and check-ups) is as good as or better than immediate biopsy for people with small thyroid nodules that look suspicious on ultrasound. Twenty adults with nodules under 2 cm will be randomly assigned to either immediate biopsy or active monitoring. The main goal is to compare anxiety levels and thyroid-related quality of life after 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that active monitoring is a safe and less anxiety-provoking option for some thyroid nodules, potentially reducing unnecessary biopsies.
- What could go wrong
- This is a very small pilot study with only 20 participants, so results may not apply to everyone. It is designed to test feasibility, not to prove which approach is better.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must be ≥18 years of age. * Participants must be able and willing to provide informed consent or have a surrogate capable of providing same. * Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient. * Participants' thyroid nodule must have a TI-RADS rating of 4 or 5. * Participants thyroid nodule must be ≤2 cm in largest diameter. * Participants must be being considered for biopsy. * Participants with a prior history of papillary thyroid cancer are eligible. Exclusion Criteria: Patients who fall into one of the following categories will NOT be eligible for this study: * Adults who are unable to provide informed consent. * Patients for whom biopsy is not a consideration. * Patients with a prior history of thyroid cancer other than papillary thyroid cancer. * Patients with a history of radiation to the neck. * Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue). * Patients who have ultrasound evidence of one or more of the following: * Airway invasion of the nodule. * Nodule adjacency to/invading the recurrent nerve. * Extra-thyroidal invasion by the nodule. * Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care) * Patients who have already had a biopsy of the nodule being considered for inclusion in the study. TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria Inclusion Criteria for Study Patient Participants: * Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study. * Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team. Exclusion Criteria for Study Patient Participants: -Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study. Inclusion Criteria for Study Staff Participants: * Staff must be willing to audio record their communications with patients about enrolling in the study. * Staff must be willing to participate in interviews with QRI team about their views of the study. Exclusion Criteria for Study Staff Participants: -Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dartmouth Hitchcock Medical Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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