NCT05711264

Brief Summary

  1. 1.Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary.
  2. 2.Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 13, 2023

Last Update Submit

January 31, 2023

Conditions

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (1)

  • Role of CD4+CD28 null T helper lymphocytes in monitoring response to therapy in AIHA using flowcytometry in serum of AIHA patients.

    The potential role of CD4+CD28 null T lymphocytes in monitoring response to therapy in AIHA . the percentage of circulating CD4+CD28 null T helper lymphocytes in AIHA either Idiopathic or Secondary using flowcytometry in serum of AIHA patients.

    Baseline

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All newly diagnosed patients with AIHA without taking current steroid therapy ,other concurrent chronic inflammatory conditions ,recent blood transfusion or active Hepatitis C virus

You may qualify if:

  • newly diagnosed patients with AIHA 2- patients with idiopathic or secondary AIHA

You may not qualify if:

  • current steroid therapy 2- other concurrent chronic inflammatory conditions 3-recent blood transfusion 4- active Hepatitis C virus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Barcellini W. New Insights in the Pathogenesis of Autoimmune Hemolytic Anemia. Transfus Med Hemother. 2015 Sep;42(5):287-93. doi: 10.1159/000439002. Epub 2015 Sep 7.

    PMID: 26696796BACKGROUND

  • Youssef SR, Elsalakawy WA. First report of expansion of CD4+/CD28 null T-helper lymphocytes in adult patients with idiopathic autoimmune hemolytic anemia. Hematol Transfus Cell Ther. 2021 Oct-Dec;43(4):396-401. doi: 10.1016/j.htct.2020.04.010. Epub 2020 Jul 16.

    PMID: 32709527BACKGROUND

  • Fattizzo B, Barcellini W. Autoimmune Cytopenias in Chronic Lymphocytic Leukemia: Focus on Molecular Aspects. Front Oncol. 2020 Jan 10;9:1435. doi: 10.3389/fonc.2019.01435. eCollection 2019.

    PMID: 31998632BACKGROUND

  • Jager U, Barcellini W, Broome CM, Gertz MA, Hill A, Hill QA, Jilma B, Kuter DJ, Michel M, Montillo M, Roth A, Zeerleder SS, Berentsen S. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting. Blood Rev. 2020 May;41:100648. doi: 10.1016/j.blre.2019.100648. Epub 2019 Dec 5.

    PMID: 31839434BACKGROUND

  • Broux B, Markovic-Plese S, Stinissen P, Hellings N. Pathogenic features of CD4+CD28- T cells in immune disorders. Trends Mol Med. 2012 Aug;18(8):446-53. doi: 10.1016/j.molmed.2012.06.003. Epub 2012 Jul 10.

    PMID: 22784556BACKGROUND

  • Thewissen M, Somers V, Hellings N, Fraussen J, Damoiseaux J, Stinissen P. CD4+CD28null T cells in autoimmune disease: pathogenic features and decreased susceptibility to immunoregulation. J Immunol. 2007 Nov 15;179(10):6514-23. doi: 10.4049/jimmunol.179.10.6514.

    PMID: 17982040BACKGROUND

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Amira ehab

CONTACT

01005305860amira.ehab99@yahoo.com

Nada Osman, lecturer

CONTACT

01066937438drnadaosman911@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in clinical pathology department

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 2, 2023

Study Start

January 30, 2023

Primary Completion

January 30, 2025

Study Completion

April 1, 2025

Last Updated

February 2, 2023

Record last verified: 2023-01