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Completed

NCT Number: NCT07652450

Incidental Thyroid Cancer in Cases With Inflammatory Thyroid Lesion

This study aim to assess for the incidence of thyroid cancer in patients with autoimmune thyroiditis (Inflammatory thyroid Lesions)

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Key information

Conditions

Papillary Thyroid Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Autoimmune Diseases Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Follicular Thyroid Cancer Hashimoto Disease Hashimoto's Thyroiditis Head and Neck Neoplasms Immune System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Thyroid Cancer, Papillary Thyroid Diseases Thyroid Neoplasms Thyroiditis Thyroiditis, Autoimmune

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine

Minya, Minya Governorate, 61611, Egypt

About this study

The relationship between chronic inflammation and carcinogenesis is well established in multiple organ systems, including the liver, stomach, and colon. In the thyroid, chronic lymphocytic infiltration may create a pro-inflammatory microenvironment that promotes cellular proliferation, DNA damage, and oncogenic transformation. Several studies have suggested an increased risk of thyroid cancer, particularly papillary thyroid carcinoma (PTC), in patients with Hashimoto thyroiditis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All types of autoimmune thyroiditis, including:
  • Graves' disease
  • Toxic multinodular goiter (TMNG)
  • Toxic nodule (TN)
  • Hashimoto thyroiditis
  • Unspecified toxic nodular goiter
  • Age between 18 and 60 years
  • Underwent thyroid surgical operation (lobectomy or total thyroidectomy)

Exclusion criteria

  • Patients with known differentiated thyroid cancer before surgery
  • Recurrent thyroid disease (previous thyroid surgery)
  • Patients unfit for operation (American Society of Anesthesiologists grade IV or V)
  • Incomplete histopathological data
  • Patients with medullary thyroid carcinoma or anaplastic thyroid cancer

Treatment and study plan

total thyroidectomy

Other

Diagnosis of differentiated thyroid cancer: The presence of thyroid cancer was determined based on histopathological examination of the resected specimen

Primary outcomes

  1. • Incidence of incidental differentiated thyroid cancer with autoimmune thyroiditis

    Time frame: At time of surgery (postoperative histopathology)

    Title: Incidence of incidental differentiated thyroid cancer

    Unit of measure: % of patients (proportion)

    Metric/method: Histopathological examination of surgical specimen

Secondary outcomes

  1. Incidence of incidental differentiated thyroid cancer by autoimmune thyroiditis subtype

    Time frame: At time of surgery

    Unit of Measure

    Percentage of patients within each subtype (Hashimoto thyroiditis, Graves' disease, toxic nodular goiter)

    Metric / Method

    Histopathological classification of thyroiditis subtype and cancer diagnosis; comparison using Chi-square test or Fisher's exact test

  2. Outcome 3A: Age comparison

    Time frame: At time of surgery

    Outcome Measure Title Mean age difference between patients with and without incidental differentiated thyroid cancer Unit of Measure Years (mean ± standard deviation) Metric / Method Unpaired Student's t-test or Mann-Whitney U test

  3. Outcome 3B: Sex distribution

    Time frame: Preoperative (within 30 days before surgery)

    Field Entry Outcome Measure Title Proportion of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies who have incidental differentiated thyroid cancer Unit of Measure Percentage of patients Metric / Method Serological testing (anti-TPO antibodies measured by immunoassay); Chi-square test or logistic regression for association

  4. Secondary Outcome 4 - Tumor characteristics Outcome 4A: Tumor size

    Time frame: At time of surgery

    Outcome Measure Title Maximum tumor diameter in incidental differentiated thyroid cancers Unit of Measure Centimeters (mean ± standard deviation and range) Metric / Method Pathological measurement of surgical specimen

  5. Outcome 4B: Microcarcinoma proportion

    Time frame: At time of surgery

    Outcome Measure Title Proportion of incidental thyroid cancers that are microcarcinomas (≤1 cm) Unit of Measure Percentage of patients with incidental cancer Metric / Method Pathological measurement; defined as tumor size ≤1 cm

  6. Outcome 4C: Lymph node metastasis

    Time frame: At time of surgery

    Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have lymph node metastasis Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination of central neck dissection specimens

  7. Outcome 4D: Multifocality

    Time frame: At time of surgery

    Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have multifocal disease Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (two or more distinct tumor foci)

  8. Outcome 3E: Extrathyroidal extension

    Time frame: At time of surgery

    Outcome Measure Title Proportion of patients with incidental differentiated thyroid cancer who have extrathyroidal extension Unit of Measure Percentage of patients with incidental cancer Metric / Method Histopathological examination (minimal or extensive extension)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Incidental Thyroid Cancer in Patients With Inflammatory Thyroid Lesions: A Cohort Study From a Tertiary Care Center

Acronym: Thyroid cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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