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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Minia University Hospital
RECRUITING
Minya
Contact Information
Primary
Saleh K Saleh, MD
salehkhairy@mu.edu.eg
01201765401
Backup
Rabeh K Saleh, MD
Rabeh.Saleh@mu.edu.eg
01220065443
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 280
Treatments
Graves' Disease Undergoing Thyroidectomy
Remove of both thyroid lobes and isthmus
Sponsors
Leads: Minia University

This content was sourced from clinicaltrials.gov

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