Compares immediate biopsy with active monitoring for suspicious thyroid nodules
Compares immediate biopsy with ultrasound monitoring in adults with suspicious thyroid nodules.
Plain-language title generated from the registry record
Registry title: TRAIL Study: Feasibility and Pilot
Key facts
- Where
- Lebanon, United StatesSee the site
Where in United States
- Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dartmouth-Hitchcock Medical Center
- Trial code
- NCT06220656
- Record updated
- 23 March 2026
- Original description
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.Read full original descriptionShow less
ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
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)
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: Patients with a prior history of thyroid cancer other than papillary thyroid cancer; Patients with a history of radiation to the neck; 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 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; TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria; -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.