TRAIL Study: Feasibility and Pilot

NCT ID: NCT06220656

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-06-30

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. immediate biopsy (usual care)

2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)

Conditions

Thyroid Nodule; Thyroid Neoplasms; Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate biopsy (usual care)

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: 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, proceeding to biopsy if needed

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.

Group Type: EXPERIMENTAL

Active Monitoring

Intervention Type: 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.

Interventions

Biopsy

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.

Intervention Type: PROCEDURE

Active Monitoring

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• 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.

• 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

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.

-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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Radiology

OTHER

Sponsor Role: collaborator

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Louise Davies

Staff Physician - Section of Otolaryngology Head & Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Davies, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michaela M Geffert, BS

Role: CONTACT

michaela.m.geffert@hitchcock.org

(603) 305-3529

Facility Contacts

Michaela M Geffert, BS

Role: primary

michaela.m.geffert@hitchcock.org

603-650-2054

Other Identifiers

23DAV058

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY02002058

Identifier Type: -

Identifier Source: org_study_id