What this study is
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)
What's being tested
- Biopsy
Intervention · PROCEDURE
Local anesthetic is usually given and a small needle is used to take cells from the thyroid under ultrasound guidance through several 'passes' and placed into specialized media for pathology evaluation.
- Active Monitoring
Intervention · PROCEDURE
Ultrasound and a check-up at 6 months. Depending on ultrasound results, either biopsy and further care (as for the treatment arm called 'biopsy'), or continue with active monitoring.
Study details
- Official title
- ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Conditions
- Thyroid Nodule · Thyroid Neoplasms · Thyroid Cancer
- Enrolling
- 20 people
- Starts
- 2025-05-01
- Est. completion
- 2027-06
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedStudy Patient Participants
You may qualify if
- 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.
You can't join if
- 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.
- 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
Study Staff Participants
You may qualify if
- 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.
- 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.
You can't join if
- 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.
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
- Michaela M Geffert, BS · Contact603-650-2054michaela.m.geffert@hitchcock.org
- Louise Davies, MD, MS · Principal investigator
Recruiting
Study team
Sponsor
Dartmouth-Hitchcock Medical Center
Study ID STUDY02002058
Principal investigator
Louise Davies, MD, MS
Dartmouth-Hitchcock Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.