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RECRUITING
NCT06220656
NA

TRAIL Study: Feasibility and Pilot

Sponsor: Dartmouth-Hitchcock Medical Center

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-01

Completion Date

2027-06

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy

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.

PROCEDURE

Active 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