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New treatment option for Thyroid Nodule
Official title TRAIL Study: Feasibility and Pilot
ClinicalTrials.gov ID: NCT06220656
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.