Thyroid CancerGDNCT07059507
Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.
An observational study of Thyroid Cancer and Graves Disease, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Cancer, Graves Disease
- What is being tested?
- Total thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 15 Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with Graves' disease undergoing total thyroidectomy at Minia University Hospital, a tertiary care center with specialized endocrine surgery services.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia University Hospital
Minya, Minya Governorate, 61519
Saleh K Saleh, 01201765401 ext. +2, salehkhairy@mu.edu.eg
Rabeh K Saleh, MD
About this study
Official title: Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy: A Prospective Study.
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.
Read the detailed description
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:
- Presence of Nodules: The presence of thyroid nodules within the diffuse goiter of GD is a consistently reported risk factor for ITC.
- Age: Some studies suggest older age is a risk factor. However others, identified younger age as a predictor. This discrepancy requires further investigation.
- Sex: Male sex has been identified as a risk factor in some studies, although GD is much more prevalent in females.
- Body Mass Index (BMI): patients with cancer had a higher BMI.
- Thyroid Autoantibodies and Thyroglobulin: thyroid peroxidase antibodies (TPOAbs), thyroglobulin antibody(TgAbs), and thyroglobulin(Tg) levels but found no statistically significant differences between benign and malignant groups in their cohort undergoing total thyroidectomy for benign diseases. The role of specific GD-related antibodies (e.g., thyroid-stimulating hormone (TSH) receptor antibodies) as predictors requires further study.
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.
- Conditions
- Thyroid Cancer, Graves Disease
- Being tested
- Total thyroidectomy
- Keywords
- Incidental thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomyProcedure or surgery
Remove of both thyroid lobes and isthmus
| Study group | Role | What they receive |
|---|---|---|
| Graves' Disease Undergoing Thyroidectomy | Remove of both thyroid lobes and isthmus Receives: Procedure: Total thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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).
Measured: 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).
Measured: Assessed at the time of final pathology report post-surgery (within 30 days post-operation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jul 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Khairy Saleh MD, Minia University
- Investigators
- Saleh K Saleh, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059507
- Sponsor's protocol ID
- 1574/06/2025
- Acronym
- GD
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moronta S, Slattery L, Wang R, Nwariaku F, McMullin JL. Incidental Thyroid Cancer in Patients With Graves' Disease: Not as Rare as We Previously Believed. J Surg Res. 2025 Apr;308:122-128. doi: 10.1016/j.jss.2025.02.024. Epub 2025 Mar 17.
PubMed 40101333Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229.
PubMed 27521067Patel KN, Yip L, Lubitz CC, Grubbs EG, Miller BS, Shen W, Angelos P, Chen H, Doherty GM, Fahey TJ 3rd, Kebebew E, Livolsi VA, Perrier ND, Sipos JA, Sosa JA, Steward D, Tufano RP, McHenry CR, Carty SE. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults. Ann Surg. 2020 Mar;271(3):e21-e93. doi: 10.1097/SLA.0000000000003580.
PubMed 32079830Staniforth JUL, Erdirimanne S, Eslick GD. Thyroid carcinoma in Graves' disease: A meta-analysis. Int J Surg. 2016 Mar;27:118-125. doi: 10.1016/j.ijsu.2015.11.027. Epub 2015 Nov 26.
PubMed 26626367Phitayakorn R, McHenry CR. Incidental thyroid carcinoma in patients with Graves' disease. Am J Surg. 2008 Mar;195(3):292-7; discussion 297. doi: 10.1016/j.amjsurg.2007.12.006.
PubMed 18206132You E, Mascarella MA, Al Jassim A, Forest VI, Hier MP, Tamilia M, Pusztaszeri M, Payne RJ. Prevalence and aggressiveness of papillary thyroid carcinoma in surgically-treated graves' disease patients: a retrospective matched cohort study. J Otolaryngol Head Neck Surg. 2019 Aug 28;48(1):40. doi: 10.1186/s40463-019-0364-5.
PubMed 31462328Askitis D, Efremidou EI, Karanikas M, Mitrakas A, Tripsianis G, Polychronidis A, Liratzopoulos N. Incidental thyroid carcinoma diagnosed after total thyroidectomy for benign thyroid diseases: incidence and association with thyroid disease type and laboratory markers. Int J Endocrinol. 2013;2013:451959. doi: 10.1155/2013/451959. Epub 2013 Nov 20.
PubMed 24348554Hay ID, Hutchinson ME, Gonzalez-Losada T, McIver B, Reinalda ME, Grant CS, Thompson GB, Sebo TJ, Goellner JR. Papillary thyroid microcarcinoma: a study of 900 cases observed in a 60-year period. Surgery. 2008 Dec;144(6):980-7; discussion 987-8. doi: 10.1016/j.surg.2008.08.035.
PubMed 19041007
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy: A Prospective Study.
- ClinicalTrials.gov ID
- NCT07059507
- Acronym / sponsor ID
- GD / 1574/06/2025
- Conditions
- Thyroid Cancer, Graves Disease
- Keywords
- Incidental thyroid cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Presence of Nodules: The presence of thyroid nodules within the diffuse goiter of GD is a consistently reported risk factor for ITC.
- Age: Some studies suggest older age is a risk factor. However others, identified younger age as a predictor. This discrepancy requires further investigation.
- Sex: Male sex has been identified as a risk factor in some studies, although GD is much more prevalent in females.
- Body Mass Index (BMI): patients with cancer had a higher BMI.
- Thyroid Autoantibodies and Thyroglobulin: thyroid peroxidase antibodies (TPOAbs), thyroglobulin antibody(TgAbs), and thyroglobulin(Tg) levels but found no statistically significant differences between benign and malignant groups in their cohort undergoing total thyroidectomy for benign diseases. The role of specific GD-related antibodies (e.g., thyroid-stimulating hormone (TSH) receptor antibodies) as predictors requires further study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graves' Disease Undergoing Thyroidectomy | – | Procedure: Total thyroidectomyRemove of both thyroid lobes and isthmus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Graves' disease undergoing total thyroidectomy at Minia University Hospital, a tertiary care center with specialized endocrine surgery services.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total thyroidectomyRemove of both thyroid lobes and isthmus | Procedure or surgery | Graves' Disease Undergoing Thyroidectomy |
Primary outcome
Prevalence of Incidental Thyroid Carcinoma (ITC)
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.
The proportion of patients with histologically confirmed incidental thyroid carcinoma, including microcarcinomas, among those undergoing total thyroidectomy for Graves' disease.
2 secondary outcomes
Factors Associated with Incidental Thyroid Carcinoma (ITC) Risk.
Time frame: Assessed at the time of data analysis, approximately 1 year after enrollment completion.
Histopathological Characteristics of Incidental Thyroid Carcinoma.
Time frame: Assessed at the time of final pathology report post-surgery (within 30 days post-operation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 40101333Moronta S, Slattery L, Wang R, Nwariaku F, McMullin JL. Incidental Thyroid Cancer in Patients With Graves' Disease: Not as Rare as We Previously Believed. J Surg Res. 2025 Apr;308:122-128. doi: 10.1016/j.jss.2025.02.024. Epub 2025 Mar 17.
- Background: PubMed 27521067Ross DS, Burch HB, Cooper DS, Greenlee MC, Laurberg P, Maia AL, Rivkees SA, Samuels M, Sosa JA, Stan MN, Walter MA. 2016 American Thyroid Association Guidelines for Diagnosis and Management of Hyperthyroidism and Other Causes of Thyrotoxicosis. Thyroid. 2016 Oct;26(10):1343-1421. doi: 10.1089/thy.2016.0229.
- Background: PubMed 32079830Patel KN, Yip L, Lubitz CC, Grubbs EG, Miller BS, Shen W, Angelos P, Chen H, Doherty GM, Fahey TJ 3rd, Kebebew E, Livolsi VA, Perrier ND, Sipos JA, Sosa JA, Steward D, Tufano RP, McHenry CR, Carty SE. The American Association of Endocrine Surgeons Guidelines for the Definitive Surgical Management of Thyroid Disease in Adults. Ann Surg. 2020 Mar;271(3):e21-e93. doi: 10.1097/SLA.0000000000003580.
- Background: PubMed 26626367Staniforth JUL, Erdirimanne S, Eslick GD. Thyroid carcinoma in Graves' disease: A meta-analysis. Int J Surg. 2016 Mar;27:118-125. doi: 10.1016/j.ijsu.2015.11.027. Epub 2015 Nov 26.
- Background: PubMed 18206132Phitayakorn R, McHenry CR. Incidental thyroid carcinoma in patients with Graves' disease. Am J Surg. 2008 Mar;195(3):292-7; discussion 297. doi: 10.1016/j.amjsurg.2007.12.006.
- Background: PubMed 31462328You E, Mascarella MA, Al Jassim A, Forest VI, Hier MP, Tamilia M, Pusztaszeri M, Payne RJ. Prevalence and aggressiveness of papillary thyroid carcinoma in surgically-treated graves' disease patients: a retrospective matched cohort study. J Otolaryngol Head Neck Surg. 2019 Aug 28;48(1):40. doi: 10.1186/s40463-019-0364-5.
- Background: PubMed 24348554Askitis D, Efremidou EI, Karanikas M, Mitrakas A, Tripsianis G, Polychronidis A, Liratzopoulos N. Incidental thyroid carcinoma diagnosed after total thyroidectomy for benign thyroid diseases: incidence and association with thyroid disease type and laboratory markers. Int J Endocrinol. 2013;2013:451959. doi: 10.1155/2013/451959. Epub 2013 Nov 20.
- Background: PubMed 19041007Hay ID, Hutchinson ME, Gonzalez-Losada T, McIver B, Reinalda ME, Grant CS, Thompson GB, Sebo TJ, Goellner JR. Papillary thyroid microcarcinoma: a study of 900 cases observed in a 60-year period. Surgery. 2008 Dec;144(6):980-7; discussion 987-8. doi: 10.1016/j.surg.2008.08.035.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saleh K Saleh, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Graves Disease, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saleh K Saleh, MD (01201765401 ext. +2, salehkhairy@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Incidental Thyroid Carcinoma (ITC) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07059507, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.