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

NCT07059507 | Recruiting DMC

• 1 other identifier: 1574/06/2025
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer; Graves Disease

Keywords

Incidental thyroid cancer

Outcome Measures

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.

  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.

  Assessed at the time of data analysis, approximately 1 year after enrollment completion.

• Histopathological Characteristics of Incidental Thyroid Carcinoma.

  Assessed at the time of final pathology report post-surgery (within 30 days post-operation).

Study Arms (1)

Graves' Disease Undergoing Thyroidectomy

Remove of both thyroid lobes and isthmus

Procedure: Total thyroidectomy

Interventions

Total thyroidectomy PROCEDURE

Remove of both thyroid lobes and isthmus

Graves' Disease Undergoing Thyroidectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with Graves' disease undergoing total thyroidectomy at Minia University Hospital, a tertiary care center with specialized endocrine surgery services.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 40101333 BACKGROUND

• Ross 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.

  PMID: 27521067 BACKGROUND

• Patel 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.

  PMID: 32079830 BACKGROUND

• Staniforth 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.

  PMID: 26626367 BACKGROUND

• Phitayakorn 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.

  PMID: 18206132 BACKGROUND

• You 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.

  PMID: 31462328 BACKGROUND

• Askitis 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.

  PMID: 24348554 BACKGROUND

• Hay 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.

  PMID: 19041007 BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms; Graves Disease

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Rabeh K Saleh, MD

CONTACT

01220065443; Rabeh.Saleh@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)