Thyroid NoduleNCT06220656
TRAIL Study: Feasibility and Pilot
A study testing Biopsy and Active Monitoring in people with Thyroid Nodule and Thyroid Neoplasms, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- What is being tested?
- Biopsy and Active Monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Participants with a prior history of papillary thyroid cancer are eligible.
- 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.
Who cannot join
- 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).
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- 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
- -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.
- -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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Michaela M Geffert, BS, 603-650-2054, michaela.m.geffert@hitchcock.org
Louise Davies, MD, MS
About this study
Official title: ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
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:
- immediate biopsy (usual care)
- Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
- Conditions
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- Being tested
- Biopsy, Active Monitoring
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
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.
Active MonitoringProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate biopsy (usual care) | Experimental | The aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently.
If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects. Receives: Procedure: Biopsy |
| Active monitoring, proceeding to biopsy if needed | Experimental | The aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that.
If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above. Receives: Procedure: Active Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anxiety at 6 months
Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.
Measured: 6 months after randomization
Secondary outcomes (6)
Representativeness of enrolled participants compared to eligible participants
Representativeness will be compared in terms of age in years (continuous), biological male or female (categorical), and race/ethnicity (categorical).
Measured: 6 months after randomization.
Study Procedure compliance
Rate of completion of patient reported outcomes and number of participants who withdraw from study or are lost to follow-up.
Measured: 6 months after randomization
Clinical outcomes: needle biopsy cytology results (if done),
A needle biopsy is a procedure to obtain samples of tissue or cells from thyroid nodule or lymph nodes to reveal whether a nodule is a benign tumor or cancer. Bethesda classification (ordinal) will be used. The Bethesda system identifies six diagnostic categories on thyroid nodule cytopathology. Each category is linked to a malignancy risk. Categories are as follows: Category I (Nondiagnostic), Category II (Benign), Category III (Atypical of undetermined significance), Category IV (Suspicious for follicular neoplasm), Category V (suspicious for malignancy), Category VI (Malignant). If Cytology results shows Bethesda V or VI, then histology (categorical) will be performed.
Measured: 6 months after randomization.
Clinical outcomes: pathology at surgery (if surgery performed),
Histologic examination (Categorical) will be performed to make diagnosis. Histology is a medical practice to review tissues under microscope to identify potential changes in a suspected tissue. The histological exam will help to diagnose if cancer is present or not and to find out the histologic type of the suspected tissue. The histologic types for thyroid cancer are as follows: Papillary, follicular, oncocytic, medullary, and anaplastic.
Measured: 6 months after randomization.
Clinical outcomes; Nodule size
If patient is on active monitoring, then the nodule size will be followed with ultrasound exams.
Measured: Baseline and 6 months after randomization.
Score on selected domains of the ThyPRO short form instrument
The ThyPRO survey is a quality-of-life measure designed to evaluate how thyroid disease has affected the participant's life. Domains being used from this measure for the pilot study include symptoms (8 items), tiredness (2 items), and memory and concentration (3 items). Answer choices range from 1 (not at all) to 5 (very much) with higher scores indicating worse quality of life.
Measured: 3 and 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 May 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Radiology, Dartmouth College
- Responsible party
- Principal investigator, Louise Davies, Dartmouth-Hitchcock Medical Center
- Investigators
- Louise Davies, MD, MS, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220656
- Sponsor's protocol ID
- STUDY02002058
- Other IDs
- 23DAV058
- Status last verified
- Mar 2026
- First submitted
- 22 Dec 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThyRoid Active Monitoring and Intervention Longitudinal (TRAIL) Study: Feasibility and Pilot
- ClinicalTrials.gov ID
- NCT06220656
- Acronym / sponsor ID
- STUDY02002058
- Conditions
- Thyroid Nodule, Thyroid Neoplasms, Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American College of Radiology, Dartmouth College
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- immediate biopsy (usual care)
- Active monitoring (serial ultrasound based monitoring and close clinical follow-up)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate biopsy (usual care) | Experimental | Procedure: BiopsyThe aim of biopsy is to sample the thyroid nodule so that it can be tested for cancer. A biopsy is done with a small needle in an office. If the biopsy result shows the nodule is unlikely to be cancer, the next step is check-ups every 6 months to a year for two years followed by additional checkups that occur less frequently. If the biopsy result shows the nodule may be cancerous, usual treatment is surgery to remove part or all of the thyroid gland. Afterwards, regular check-ups and ultrasounds follow. Surgery may be outpatient or overnight stay. Recovery takes a couple weeks or more. Time in the hospital and recovering depends on the type of operation and any side-effects. |
| Active monitoring, proceeding to biopsy if needed | Experimental | Procedure: Active MonitoringThe aim of Active Monitoring is to monitor the thyroid nodule closely. An ultrasound and a check-up with a clinician are done every six months for two years, then less often after that. If no changes in the nodule or new abnormal lymph nodes are seen, Active Monitoring continues and surgery and its side-effects are avoided. If changes in the nodule are seen on ultrasound, they are explained at the visit. The doctor may recommend that continued Active Monitoring or recommend a biopsy to investigate the changes. The biopsy result may suggest Active Monitoring can be continued, or may indicate surgery should be done, as described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyLocal 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 or surgery | Immediate biopsy (usual care) |
| Active MonitoringUltrasound 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. | Procedure or surgery | Active monitoring, proceeding to biopsy if needed |
Primary outcome
Rate of Anxiety at 6 months
Time frame: 6 months after randomization
Rate of anxiety will be measured using Anxiety-CA instrument PROMIS-Anxiety Short form. Each question has five response options ranging in value from one to five. (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion). To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the adult PROMIS Anxiety 7a short form, a raw score of 10 converts to a T-score of 46.7 with a standard error (SE) of 2.6.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise Davies, MD, MS principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and Active Monitoring in people with Thyroid Nodule and Thyroid Neoplasms, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaela M Geffert, BS ((603) 305-3529, michaela.m.geffert@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anxiety at 6 months (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.