Thyroid NoduleNCT05264857
Decision Aid and Thyroid Nodules Management
A study testing Thyroid Nodule Management Education in people with Thyroid Nodule, run by Stony Brook University at 1 site in United States.
Trial summary
Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule
- What is being tested?
- Thyroid Nodule Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 30 Sep 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
- Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
- Thyroid nodule size less or equal to 2cm
Who cannot join
- History of thyroid surgery
- History of thyroid cancer
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
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Jessica Alfano, jessica.alfano@stonybrookmedicine.edu
Caterina Vacchi-Suzzi, 6312162993, caterina.vacchi-suzzi@stonybrookmedicine.edu
About this study
Official title: Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer
Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.
- Conditions
- Thyroid Nodule
- Being tested
- Thyroid Nodule Management Education
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid Nodule Management EducationBehavioural
Participants will receive information about thyroid nodules and their management
| Study group | Role | What they receive |
|---|---|---|
| Thyroid nodule information | Experimental | Not described Receives: Behavioral: Thyroid Nodule Management Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of congruence between informed values and treatment choice
Percent of patients with congruence between treatment option and informed values based on a survey
Measured: 6 months from surgery or surgical consultation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start8 Feb 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Czerwonka, Stony Brook University
- Investigators
- Lukasz Czerwonka, MD, Principal investigator, Lukasz.Czerwonka@stonybrookmedicine.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264857
- Sponsor's protocol ID
- SBU-DECISION-AID-THYROID
- Status last verified
- Oct 2025
- First submitted
- 17 Feb 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer
- ClinicalTrials.gov ID
- NCT05264857
- Acronym / sponsor ID
- SBU-DECISION-AID-THYROID
- Conditions
- Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 Mar 2022 (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.
Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid nodule information | Experimental | Behavioral: Thyroid Nodule Management Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
- Thyroid nodule size less or equal to 2cm
Key exclusion criteria (2 listed)
- History of thyroid surgery
- History of thyroid cancer
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 |
|---|---|---|
| Thyroid Nodule Management EducationParticipants will receive information about thyroid nodules and their management | Behavioural | Thyroid nodule information |
Primary outcome
Rate of congruence between informed values and treatment choice
Time frame: 6 months from surgery or surgical consultation date
Percent of patients with congruence between treatment option and informed values based on a survey
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 14 Oct 2025.
- 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.
Lukasz Czerwonka, MD principal investigator
Lukasz.Czerwonka@stonybrookmedicine.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroid Nodule Management Education in people with Thyroid Nodule, run by Stony Brook University 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 2 inclusion and 2 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 14 Oct 2025. 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 Jessica Alfano (631-216-2993, jessica.alfano@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of congruence between informed values and treatment choice (time frame: 6 months from surgery or surgical consultation date). 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 14 Oct 2025.