TRAIL Study: Feasibility and Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biopsy, Active Monitoring.
- Who it may be relevant to
- Registry conditions: Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
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)
Interventions
- Procedure 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. - 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.
Primary outcome measures
- Rate of Anxiety at 6 months [Time frame: 6 months after randomization]
Secondary outcome measures (6)
- Representativeness of enrolled participants compared to eligible participants [Time frame: 6 months after randomization.]
- Study Procedure compliance [Time frame: 6 months after randomization]
- Clinical outcomes: needle biopsy cytology results (if done), [Time frame: 6 months after randomization.]
- Clinical outcomes: pathology at surgery (if surgery performed), [Time frame: 6 months after randomization.]
- Clinical outcomes; Nodule size [Time frame: Baseline and 6 months after randomization.]
- Score on selected domains of the ThyPRO short form instrument [Time frame: 3 and 6 months post randomization]
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dartmouth Hitchcock Medical Center — Lebanon
Identifiers
NCT: NCT06220656 · STUDY02002058 · 23DAV058