Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMinia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Patient is scheduled for total thyroidectomy (near-total or subtotal thyroidectomy patients will be excluded).
Ability and willingness to provide written informed consent.
Disqualifiers
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.
Trial population
Adult patients diagnosed with Graves' disease undergoing total thyroidectomy at Minia University Hospital, a tertiary care center with specialized endocrine surgery services.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total thyroidectomy
Procedure/SurgeryRemove of both thyroid lobes and isthmus
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: Graves' Disease Undergoing Thyroidectomy1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of Incidental Thyroid Carcinoma (ITC)
The proportion of patients with histologically confirmed incidental thyroid carcinoma, including microcarcinomas, among those undergoing total thyroidectomy for Graves' disease.
Time frame
Assessed at the time of final pathology report post-surgery (within 30 days post-operation).Histopathological examination of thyroidectomy specimens using standardized protocols.Secondary outcomes
1
Factors Associated with Incidental Thyroid Carcinoma (ITC) Risk.
Identification of predictors for incidental thyroid carcinoma (ITC) through univariate and multivariate logistic regression analysis of preoperative clinical, laboratory, imaging, and demographic data. Factors to be assessed include, but are not limited to, presence of nodules, age, sex, and Body Mass Index (BMI).
Time frame
Assessed at the time of data analysis, approximately 1 year after enrollment completion.2
Histopathological Characteristics of Incidental Thyroid Carcinoma.
Frequency and percentage of ITC characteristics (e.g., histological type, size, stage, multifocality).
Time frame
Assessed at the time of final pathology report post-surgery (within 30 days post-operation).Sponsors and contacts
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Source ClinicalTrials.gov