An observational study in Thyroid Cancer and Graves Disease, sponsored by Minia University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Minia University · Observational
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.
Graves' disease (GD) is the most common cause of hyperthyroidism, affecting approximately 0.5% of the US population.
While definitive treatment often involves radioactive iodine (RAI) or antithyroid drugs (ATDs), thyroidectomy is increasingly utilized, especially for patients with large goiters, compressive symptoms, coexisting suspicious nodules, or contraindications/failure of other therapies.
However, numerous studies over the past few decades have challenged this notion, reporting varying rates of incidental thyroid carcinoma (ITC) discovered in thyroidectomy specimens from GD patients. Understanding the true prevalence and identifying predictors of incidental thyroid cancer (ITC) in this population is crucial for appropriate patient counseling, surgical decision-making, and determining the optimal extent of thyroidectomy.
Identifying factors associated with an increased risk of incidental thyroid cancer in GD patients could help stratify risk and guide management. Several potential predictors in literatures reviews have been investigated, with some conflicting results:
The study will enroll approximately 280 patients , utilizing standardized data collection (demographics, clinical history, laboratory, imaging and operative data) and pathological examination protocols. The primary outcome is the prevalence of incidental thyroid cancer (ITC), secondary outcomes including predictors and histopathological characteristics.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 280 is above the median of 178 across 241 observational studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Adult patients diagnosed with Graves' disease undergoing total thyroidectomy at Minia University Hospital, a tertiary care center with specialized endocrine surgery services.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remove of both thyroid lobes and isthmus
Procedure: Total thyroidectomy
Remove of both thyroid lobes and isthmus
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.
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.
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).
Plan to share: No
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