NCT07059507 Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.
| NCT ID | NCT07059507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Thyroid Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-07-15 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2025-07-15 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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).
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07059507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059507 currently recruiting?
Yes, NCT07059507 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07059507 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07059507 clinical trial?
NCT07059507 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 280 participants.
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