Prevalence of hidden thyroid cancer in people with Graves' disease having a total thyroidectomy.
Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy: A Prospective Study.
Minia University · NCT07059507
This project will see how common incidental thyroid cancer is in adults with Graves' disease who are having their thyroid removed and which clinical features or nodules predict it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University (other) |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07059507 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with confirmed Graves' disease who are scheduled for total thyroidectomy and are able to give informed consent.
Not a fit: People not undergoing total thyroidectomy (for example those treated with radioactive iodine or antithyroid drugs), children under 18, or patients without Graves' disease are unlikely to receive direct benefit.
Why it matters
Potential benefit: If successful, the findings could help doctors better counsel patients and choose the most appropriate surgical approach by clarifying how often incidental cancer occurs and which patients are at higher risk.
How similar studies have performed: Previous mostly retrospective series have reported variable but sometimes high rates of incidental thyroid cancer, suggesting a signal exists but prospective standardized data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minya, Minya Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer, Graves Disease, Incidental thyroid cancer