Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.

Recruiting now

Conditions studied: Thyroid Cancer, Graves Disease

In brief

The prevalence of incidental thyroid cancer (ITC) in Graves' Disease (GD) patients undergoing thyroidectomy appears higher than historically believed, potentially exceeding 10% in large contemporary series, although significant variability exists. The presence of nodules is a strong predictor, while the roles of age, sex, and BMI require clarification. Most ITCs are papillary thyroid microcarcinoma(PTMCs) with generally favorable prognoses, but concerns about aggressiveness persist. The purpose of the present study is to accurately evaluate the prevalence of incidental thyroid carcinoma (ITC), including microcarcinomas, in a prospectively enrolled cohort of patients undergoing total thyroidectomy for Graves' disease, utilizing standardized pathological examination protocols and secondary outcomes including predictors and histopathological characteristics.

Key facts

Study ID

NCT07059507

Run by

Minia University

People needed

280

Starts

2025-07-15

Expected to finish

2026-08-15

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older.
• Confirmed diagnosis of Graves' disease based on clinical features (e.g., diffuse goiter, ophthalmopathy if present) and biochemical evidence (suppressed TSH, elevated free T4 and/or T3) and/or positive TSH receptor antibody (TRAb) test.
• Indication for total thyroidectomy for Graves' disease, based on established guidelines:
• Relapse or persistence of hyperthyroidism after a course of antithyroid drugs (ATDs).
• Intolerance or adverse reaction to ATDs. Patient preference for surgery over radioactive iodine (RAI) or long-term ATDs. Presence of a large goiter causing compressive symptoms. Coexisting suspicious thyroid nodule(s) on preoperative evaluation. Moderate to severe active Graves' ophthalmopathy where RAI is relatively contraindicated.
• Patient is scheduled for total thyroidectomy (near-total or subtotal thyroidectomy patients will be excluded).
• Ability and willingness to provide written informed consent.
• Ability to understand study procedures and requirements.

You may not qualify if…

• Age less than 18 years.
• Previous thyroid surgery.
• Previous neck irradiation.
• Preoperative diagnosis of thyroid malignancy confirmed by fine-needle aspiration (FNA) cytology (Bethesda V or VI) , the focus is on incidental carcinoma.
• Inability to provide informed consent (e.g., due to cognitive impairment).
• Patients undergoing thyroidectomy primarily for reasons other than Graves' disease (e.g., primary indication is large non-toxic MNG).
• Patients undergoing less than total thyroidectomy (e.g., lobectomy, subtotal thyroidectomy).

Where it is running

• Minia University Hospital — Minya, Minya Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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