ClinicalTrials.gg
Not yet recruitingNCT06521359Updated Jul 25, 2024

Role of Follicular T Cells in Hashimoto's Thyroiditis

An observational study in Hashimoto's Thyroiditis, sponsored by Omnia Ahmed Nafea Mohamed. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Omnia Ahmed Nafea Mohamed · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
90
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

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 .

02

Conditions studied

  • Hashimoto's Thyroiditis

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03

In context

Hashimoto Disease

53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.

This study's planned enrollment of 90 is below the median of 112 across 22 observational studies indexed under Hashimoto Disease.

Browse Hashimoto Disease studies →

Lead sponsor

This is the only study on the registry with Omnia Ahmed Nafea Mohamed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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;

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.

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

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 diseases for example; type1 diabetes\&Rheumatoid arthritis,and other diseases which cause hypothyroidism as carcinoma and surgery.
Terms in these criteria, in plain language(1)

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • case

    Device: flow cytometry

  • control

    Device: flow cytometry

Interventions

  • Deviceflow cytometry

    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.

06

What researchers measure

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.

    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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06521359
Lead sponsor
Omnia Ahmed Nafea Mohamed
Responsible party
Omnia Ahmed Nafea Mohamed (doctor, Assiut University) — Sponsor-investigator
First posted
Jul 25, 2024
Start date
May 2025 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jul 25, 2024

Study contacts

Omnia Ahmed Nafea, master
Contact
mennanafea97@gmail.com
01125785008
Entsar Hamed Ahmed, Professor
Contact
01001344841

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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