Prevalence of hidden thyroid cancer in people with Graves' disease having a total thyroidectomy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational cohort will enroll adults with confirmed Graves' disease who are scheduled for total thyroidectomy and will use standardized pathological examination protocols to detect incidental thyroid carcinoma, including microcarcinomas. Surgical specimens will be processed and reported according to predefined sectioning and histopathology criteria to maximize consistent detection across cases. Clinical data including age, sex, BMI, antibody status, imaging findings, and presence of nodules will be collected to identify predictors of incidental cancer. Secondary outcomes include tumor subtype, size, and pathological features that might indicate aggressiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Minia University Hospital
  Minya, Minya Governorate, Egypt Recruiting

Study contacts

• Principal investigator: Saleh K Saleh, MD — Minia University
• Study coordinator: Saleh K Saleh, MD
• Email: salehkhairy@mu.edu.eg
• Phone: 01201765401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.