RecruitingNot ApplicableNCT06220656

TRAIL Study: Feasibility and Pilot

ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot


Sponsor

Dartmouth-Hitchcock Medical Center

Enrollment

20 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy. The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm Participants will be randomized to one of two groups: 1. immediate biopsy (usual care) 2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot feasibility study is evaluating a new approach to monitoring thyroid nodules — small lumps in the thyroid gland — using active surveillance (watchful waiting with regular imaging) instead of immediate biopsy. The study aims to assess whether this monitoring-first approach is safe and acceptable to patients and providers for nodules that are suspicious but small. **You may be eligible if...** - You are 18 or older with a thyroid nodule rated TI-RADS 4 or 5 (intermediate to high suspicion) - Your nodule is 2 cm or smaller - You are being considered for a biopsy - You do not have symptoms from the nodule (no trouble swallowing, no visible lump bothering you) - You may have a prior history of papillary thyroid cancer **You may NOT be eligible if...** - Your nodule is invading the airway or surrounding structures - Your nodule has spread to nearby lymph nodes or elsewhere - You have had radiation to the neck area - Your thyroid has been removed or you only have thyroid tissue at the base of your tongue - You have had a biopsy of this specific nodule already - You have a history of any thyroid cancer other than papillary thyroid cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Local anesthetic is usually given and a small needle is used to take cells from the thyroid under ultrasound guidance through several 'passes' and placed into specialized media for pathology evaluation.

PROCEDUREActive Monitoring

Ultrasound and a check-up at 6 months. Depending on ultrasound results, either biopsy and further care (as for the treatment arm called 'biopsy'), or continue with active monitoring.


Locations(1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

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NCT06220656


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