TRAIL Study: Feasibility and Pilot

NCT06220656 | Recruiting DMC

• 2 other identifiers: STUDY0200205823DAV058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.immediate biopsy (usual care)
2. 2.Active monitoring (serial ultrasound based monitoring and close clinical follow-up)

Conditions

Thyroid Neoplasms; Thyroid Cancer; Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• Rate of Anxiety at 6 months

  Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.

  6 months after randomization

Secondary Outcomes (6)

• Representativeness of enrolled participants compared to eligible participants

  6 months after randomization.

• Study Procedure compliance

  6 months after randomization

• Clinical outcomes: needle biopsy cytology results (if done),

  6 months after randomization.

• Clinical outcomes: pathology at surgery (if surgery performed),

  6 months after randomization.

• Clinical outcomes; Nodule size

  Baseline and 6 months after randomization.

Study Arms (2)

Immediate biopsy (usual care)

EXPERIMENTAL

The aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently. If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects.

Procedure: Biopsy

Active monitoring, proceeding to biopsy if needed

EXPERIMENTAL

The aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that. If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above.

Procedure: Active Monitoring

Interventions

Biopsy 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.

Immediate biopsy (usual care)

Active Monitoring 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.

Active monitoring, proceeding to biopsy if needed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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)
• 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.
• 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 must be willing to audio record their communications with patients about enrolling in the study.

Sponsors & Collaborators

• American College of Radiology: collaborator
• Dartmouth College: collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Louise Davies, MD, MS

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaela M Geffert, BS

CONTACT

(603) 305-3529; michaela.m.geffert@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician - Section of Otolaryngology Head & Neck Surgery

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 24, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)