NCT06521359

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started May 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

July 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 22, 2024

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

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.

    Baseline

Study Arms (2)

case

Device: flow cytometry

control

Device: flow cytometry

Interventions

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.

casecontrol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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;

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hashimoto Disease

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Thyroiditis, AutoimmuneThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Central Study Contacts

Omnia Ahmed Nafea, master

CONTACT

Entsar Hamed Ahmed, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 25, 2024

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 25, 2024

Record last verified: 2024-07