ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: P…
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.
Location
- Dartmouth Hitchcock Medical CenterLebanon, New Hampshire