NCT06220656 · Dartmouth-Hitchcock Medical Center
TRAIL Study: Feasibility and Pilot
What this study is about
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.
View original scientific 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. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
- 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 Inclusion Criteria for Study Patient Participants:
- 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. Exclusion Criteria for Study Patient Participants: -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. Inclusion Criteria for Study Staff Participants:
- 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 Criteria for Study Staff Participants: -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.
Where
- Lebanon, New Hampshire
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations