Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.
Launched by MINIA UNIVERSITY · Jul 9, 2025
Trial Information
Current as of July 14, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how often thyroid cancer is found unexpectedly in people with Graves' disease who are having their thyroid gland completely removed through surgery. Graves' disease is a condition that causes the thyroid to be overactive. Sometimes, small thyroid cancers are only found by chance during surgery, and this study wants to better understand how common these hidden cancers are, what might predict their presence, and what they look like under the microscope. Most of these cancers tend to be small and have a good outlook, but the study will also check if any behave more aggressively.
People who might join this study are adults diagnosed with Graves' disease who need surgery to remove their entire thyroid gland because other treatments haven’t worked, caused side effects, or aren’t suitable. To participate, patients must not have had previous thyroid surgery or known thyroid cancer before surgery. If you join, you’ll have your surgery as planned, and the removed thyroid will be carefully examined to see if any hidden cancer is present. This study aims to help doctors better understand the chances of finding these unexpected cancers and improve care for people with Graves' disease in the future.
Gender
ALL
Eligibility 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).
About Minia University
Minia University is a prestigious educational institution located in Egypt, dedicated to advancing medical research and clinical trials. With a commitment to fostering innovation and improving healthcare outcomes, the university collaborates with a diverse range of stakeholders, including healthcare professionals and researchers. Minia University aims to enhance clinical practices through rigorous research methodologies and ethical standards, contributing to the body of knowledge in the medical field while addressing local and global health challenges. The university's clinical trial initiatives are designed to evaluate new treatments and interventions, ensuring a positive impact on patient care and community health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minya, Minia, Egypt
Patients applied
Trial Officials
Saleh K Saleh, MD
Principal Investigator
Minia University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported