Actively Recruiting
TRAIL Study: Feasibility and Pilot
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-03-23
20
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
A
American College of Radiology
Collaborating Sponsor
AI-Summary
What this Trial 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. 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)
CONDITIONS
Official Title
TRAIL Study: Feasibility and Pilot
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Participants must be able and willing to provide informed consent or have a surrogate capable of providing consent.
- Participants must not have symptoms related to the nodule such as difficulty swallowing or a nodule that is visible or bothersome.
- Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
- Participants' thyroid nodule must be 2 cm or smaller in largest diameter.
- Participants must be considered for biopsy.
- Participants with a prior history of papillary thyroid cancer are eligible.
- Participants must be willing to allow audio recording and/or interviews if approached for the pilot study.
- Staff involved must be willing to record communications and participate in interviews about the study.
You will not qualify if you...
- Adults unable to provide informed consent.
- Patients for whom biopsy is not being considered.
- Patients with a history of thyroid cancer other than papillary thyroid cancer.
- Patients with a history of radiation to the neck.
- Patients without a thyroid gland or only lingual thyroid tissue.
- Patients with ultrasound evidence of airway invasion by the nodule.
- Patients with nodule involvement near or invading the recurrent nerve.
- Patients with extra-thyroidal invasion by the nodule.
- Patients with metastases to cervical lymph nodes or distant metastases.
- Patients who have already had a biopsy of the nodule being studied.
- Patients or staff unwilling to allow audio recording or interviews related to the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
Research Team
M
Michaela M Geffert, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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