Clinical trial NCT06220656: TRAIL Study: Feasibility and Pilot
Official title: ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Nodule
Thyroid Neoplasms
Thyroid Cancer
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: American College of Radiology
name: Dartmouth College
First posted: 2024-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Rate of Anxiety at 6 months
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Representativeness of enrolled participants compared to eligible participants
timeFrame: 6 months after randomization.
measure: Study Procedure compliance
timeFrame: 6 months after randomization
measure: Clinical outcomes: needle biopsy cytology results (if done),
timeFrame: 6 months after randomization.
measure: Clinical outcomes: pathology at surgery (if surgery performed),
timeFrame: 6 months after randomization.
measure: Clinical outcomes; Nodule size
timeFrame: Baseline and 6 months after randomization.
measure: Score on selected domains of the ThyPRO short form instrument
timeFrame: 3 and 6 months post randomization
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Louise Davies, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: