RECRUITING

TRAIL Study: Feasibility and Pilot

Description

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)

Study Overview

Study Details

Study overview

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)

ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot

TRAIL Study: Feasibility and Pilot

Condition
Thyroid Nodule
Intervention / Treatment

-

Contacts and Locations

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dartmouth-Hitchcock Medical Center,

Louise Davies, MD, MS, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

2027-06