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NCT Number: NCT06521359

Role of Follicular T Cells in Hashimoto's Thyroiditis

Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.

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Key information

About this study

Hashimoto thyroiditis, also known as chronic autoimmune thyroiditis and chronic lymphocytic thyroiditis, is an autoimmune disease in which thyroid cells are destroyed via cell and antibody-mediated immune processes. It is the most common cause of hypothyroidism in developed countries. In contrast, the most common cause of hypothyroidism worldwide is an inadequate dietary intake of iodine. The pathophysiology of Hashimoto thyroiditis involves the formation of antithyroid antibodies that attack the thyroid tissue, causing progressive fibrosis. The diagnosis can be challenging, and consequently, the condition is sometimes not diagnosed until late in the disease process. The most common laboratory findings demonstrate elevated thyroid-stimulating hormone (TSH) and low thyroxine (T4) levels, coupled with increased antithyroid peroxidase (anti-TPO) antibodies and antithyroglobulin (anti-Tg) antibodies .

Recent years have shown that Hashimoto thyroiditis development depends on an immune defect in an individual with genetic susceptibility together with environmental factors .

Who can participate

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

Inclusion criteria

  • The study will include 45 Hashimoto's patients attending the out clinics of Endocrinology Department of Assiut university hospital. In addition, 45 healthy blood donors will be included as controls. The diagnosis of hashimoto's thyroiditis will be determined according to the criteria of American Thyroid Association;
  • Having symptoms of hypothyroidism, and a blood test shows an underactive thyroid gland [an elevated thyroid stimulating hormone (TSH) level with or without a low thyroid hormone (free T4 or total T4) level].
  • have elevated thyroid antibody levels.
  • ultrasound examination demonstrating characteristic heterogeneous echotexture.
  • results of thyroid fine needle aspiration (FNA) examinations meeting HT cytology diagnostic criteria.

Exclusion criteria

  • -We should exclude other causes of thyroiditis, such as De Quervain's thyroiditis, Riedel's thyroiditis, and suppurative thyroiditis and also exclude other autoimmune diseases for example; type1 diabetes&Rheumatoid arthritis,and other diseases which cause hypothyroidism as carcinoma and surgery.

Treatment and study plan

flow cytometry

Device

Two ml of peripheral venous blood samples will be collected in heparinized tubes from patients and controls for assessment of levels of TFH and TFReg cells by flow cytometry.

Primary outcomes

  1. Measure the frequency of Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.

    Time frame: Baseline

    Measure changes in number of surface markers CD4 , ICOS, CXCR5 and FOXP3. Follicular helper Tcells and Follicular regulatory T cells in peripheral blood samples in Hashimoto's pts in comparison with control.

Study contacts

Contact information is provided by the study sponsor or research team.

Entsar Hamed Ahmed, Professor

CONTACT

01001344841

Omnia Ahmed Nafea, master

CONTACT

[email protected]

01125785008

Sponsors and collaborators

Lead sponsor

Omnia Ahmed Nafea Mohamed

Other

Registry information

Official study title

Role of Follicular Helper and Follicular Regulatory T Cells in Hashimoto's Thyroiditis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

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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