TRAIL Study: Feasibility and Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Biopsy
- Active Monitoring
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dartmouth-Hitchcock Medical Center
Lead sponsor
American College of Radiology
Collaborator
Dartmouth College
Collaborator
Source ClinicalTrials.gov