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TRAIL Study: Feasibility and Pilot | Clinical Trials | Clareo Health

RECRUITINGNA

TRAIL Study: Feasibility and Pilot

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

NCT06220656•Dartmouth-Hitchcock Medical Center

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•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.
+1 more criteria

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.
+4 more criteria

Locations (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Key Dates

Start Date

May 1, 2025

Primary Completion Date

December 1, 2025

Completion Date

June 1, 2027

Last Updated

August 26, 2025

Enrollment

ESTIMATED participants

Conditions

Thyroid NoduleThyroid NeoplasmsThyroid Cancer

Interventions

Biopsy

PROCEDURE

Active Monitoring

PROCEDURE

Contacts

Michaela M Geffert, BS

CONTACT

(603) 305-3529 michaela.m.geffert@hitchcock.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TRAIL Study: Feasibility and Pilot

Inclusion Criteria

Exclusion Criteria

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