NCT06220656Recruiting
TRAIL Study: Feasibility and Pilot
ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Dec 2023
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Thyroid cancer
- NCT number
- NCT06220656
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 May 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
Other illness
- Patients with a history of radiation to the neck.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.