Back to search results

TRAIL Study: Managing Thyroid Nodules

This pilot study is looking at two ways to manage thyroid nodules that are likely to be cancerous based on an ultrasound. These nodules would normally lead to an immediate biopsy (taking a small tissue sample). The study compares immediate biopsy to active monitoring, which involves regular ultrasounds and check-ups. Researchers want to see if one approach causes less anxiety and improves quality of life for people with these nodules. You might be able to join if you are 18 or older, have a thyroid nodule with a specific TI-RADS rating (a way doctors classify nodules), and don't have symptoms like trouble swallowing. The study aims to enroll 20 participants.

Study design
This is a pilot study comparing two approaches for thyroid nodules. Participants will be randomly assigned to either immediate biopsy or active monitoring.
What's involved
You would either undergo an immediate biopsy or have ultrasounds and check-ups at 6 months. Depending on ultrasound results, active monitoring might lead to a biopsy.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety levels will be measured at 6 months after you are assigned to a group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06220656

TRAIL Study: Feasibility and Pilot

Recruiting
NAAges 18+InterventionalTreatment
Dartmouth-Hitchcock Medical Center
~20 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:BiopsyActive Monitoring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Anxiety at 6 months
Measured over 6 months after randomization

Conditions

Thyroid Nodule
Thyroid Neoplasms
Thyroid Cancer

Explore related trials

Thyroid Gland CarcinomaThyroid Gland Nodule

Where it's being run

1 sites across 1 states
New Hampshire1

Study leadership

  • Louise Davies, MD, MS · PRINCIPAL_INVESTIGATOR · Dartmouth-Hitchcock Medical Center

Who to contact

Michaela M Geffert, BS
[email protected]
(603) 305-3529
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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.
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

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.
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.
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.

What this trial measures

  • Rate of Anxiety at 6 months6 months after randomization

    Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.