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NCT05264857 Clinical Trial

Decision Aid and Thyroid Nodules Management

Thyroid Nodule Clinical Trial

Official title:
Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05264857
Other study ID # SBU-DECISION-AID-THYROID
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 8, 2022
Est. completion date September 30, 2026

Study information
Verified date April 2023
Source Stony Brook University
Contact Carla Flores
Phone 631-444-9044
Email Carla.GomezjuradoFlores@stonybrookmedicine.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 134
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Thyroid Nodule Management Education
Participants will receive information about thyroid nodules and their management

Locations
Country Name City State
United States Stony Brook University Cancer Center Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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