Decision Aid and Thyroid Nodules Management | NCT05264857

Studies
Decision Aid and Thyroid Nodules Management

NCT05264857

Sponsor

Stony Brook University

Status

Recruiting

Last Update Posted

Oct 14, 2025Actual

Enrollment

134Estimated

Phase

Not Applicable

Conditions

Thyroid Nodule

Interventions

Thyroid Nodule Management Education

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2022Actual

Primary Completion Date

Sep 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

First Submitted Date

Feb 17, 2022

First Submission Date that Met QC Criteria

Mar 1, 2022

First Posted Date

Mar 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2025

Last Update Posted Date

Oct 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

134Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thyroid nodule information	Experimental		Behavioral: Thyroid Nodule Management Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thyroid Nodule Management Education	Behavioral	Participants will receive information about thyroid nodules and their management	Thyroid nodule information

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of congruence between informed values and treatment choice	Percent of patients with congruence between treatment option and informed values based on a survey	6 months from surgery or surgical consultation date

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)
Thyroid nodule size less or equal to 2cm

Exclusion Criteria:

History of thyroid surgery
History of thyroid cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessica Alfano	Contact	631-216-2993		jessica.alfano@stonybrookmedicine.edu
Caterina Vacchi-Suzzi	Contact	631-216-2993		caterina.vacchi-suzzi@stonybrookmedicine.edu

Overall Officials

Name	Affiliation	Role
Lukasz Czerwonka, MD	Lukasz.Czerwonka@stonybrookmedicine.edu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stony Brook University Cancer Center	Recruiting	Stony Brook	New York	11794	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided