Immediate biopsy versus active ultrasound monitoring for suspicious thyroid nodules

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized pilot comparing two management strategies for newly identified thyroid nodules judged likely to be cancerous by ultrasound. Adults with TI‑RADS 4 or 5 nodules ≤2 cm who would ordinarily be offered biopsy are randomized to immediate biopsy (usual care) or active monitoring with serial ultrasound and close clinical follow-up. The co-primary outcomes include anxiety at 6 months measured by Anxiety-CA and thyroid-specific quality of life measures, with feasibility endpoints for a larger trial. The study is conducted at Dartmouth‑Hitchcock Medical Center and is intended to inform whether surveillance can be a safe, lower-anxiety option for selected patients.

Why it matters

Who can join: the full rules

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.

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.

TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria

Inclusion Criteria for Study Patient Participants:

* 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.

Exclusion Criteria for Study Patient Participants:

-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.

Inclusion Criteria for Study Staff Participants:

* 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 for Study Staff Participants:

-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.

Where it's running

• Dartmouth Hitchcock Medical Center
  Lebanon, New Hampshire, United States Recruiting

Study contacts

• Principal investigator: Louise Davies, MD, MS — Dartmouth-Hitchcock Medical Center
• Study coordinator: Michaela M Geffert, BS
• Email: michaela.m.geffert@hitchcock.org
• Phone: (603) 305-3529

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low calcium after thyroid removal

  This project will see if clinical, lab, and surgical factors predict low calcium after thyroid surgery in adults treated at Minia University Hospital from 2014–2024.

  Recruiting Minia University · Minya, Minya Governorate · NCT07428057

• Neoadjuvant treatment response in locally advanced thyroid cancer

  This study will test whether neoadjuvant therapies can safely shrink locally advanced thyroid cancers and improve surgical outcomes for patients who then undergo thyroidectomy.

  Recruiting Fujian Medical University · Fuzhou, Fujian · NCT07419932

• Active monitoring for small Bethesda IV thyroid nodules

  This program will try active monitoring with scheduled ultrasounds and clinic visits instead of immediate surgery for adults with a single Bethesda IV thyroid nodule under 2 cm.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen · NCT07370675

• Using radiofrequency ablation to treat low-risk thyroid cancer

  This study is testing if a new treatment called radiofrequency ablation can safely help people with low-risk thyroid cancer that is 2 cm or smaller instead of traditional surgery.

  Recruiting University Health Network, Toronto · Toronto, Ontario · NCT06929650

• Improving prediction for challenging thyroid surgeries

  This study is testing a new way to predict how challenging thyroid surgeries will be by looking at different health factors to help doctors perform the surgery better.

  Recruiting Shanghai 6th People's Hospital · Shanghai · NCT06738888

• Developing a scoring tool for robotic thyroid surgery performance

  This study is trying to create a scoring tool to help doctors measure how well they perform robotic thyroid surgeries, with the aim of improving patient care.

  Recruiting Shanghai 6th People's Hospital · Shanghai · NCT06730321

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.