Autoimmune Hemolytic AnemiaNCT05711264
Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.
An observational study of Autoimmune Hemolytic Anemia, run by Assiut University.
Trial summary
1. Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary. 2. Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- 1- newly diagnosed patients with AIHA 2- patients with idiopathic or secondary AIHA
Who cannot join
- 1-current steroid therapy 2- other concurrent chronic inflammatory conditions 3-recent blood transfusion 4- active Hepatitis C virus
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Presence of Circulating CD4+CD28 Null T Helper Lymphocytes in Patients With Autoimmune Hemolytic Anemia.
- Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary.
- Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.
Read the detailed description
Autoimmune hemolytic anemia (AIHA) has always been considered the simplest and most scholastic example of antibody-mediated autoimmune disease.It has been identified as a greatly heterogeneous disease, due to several immunological mechanisms involved beyond antibodies, complement and antibody-dependent cell-mediated cytotoxicity (ADCC). AIHAs may be Idiopathic of unknown cause Secondary associated with several conditions : (lymphoproliferative, autoimmune , infectious diseases, immunodeficiencies, solid tumors, transplants, and drugs).Several subsets of T and B lymphocytes with highly specialized functions have been characterized. Some lymphocytes promote inflammation, while others have anti-inflammatory roles, and an optimal balance between these two opposing sets of lymphocytes is critical for immune homeostasis. A pro-inflammatory subset of CD4+ T helper 1 (Th1) lymphocytes known as cluster of differentiation 4 positive 28 negative T helper lymphocytes (CD4+CD28 null T cells) because they characteristically lack CD28 which is a co-stimulatory receptor critical for the activation and function of T cells.CD4+CD28 null T cells are rare in healthy individuals, but they increase in inflammatory and immune-mediated diseases. Prevalence of CD4+CD28 null T cells is high in chronic inflammatory diseases, autoimmune diseases, immunodeficiency and specific infectious diseases.It remains controversial whether CD4+CD28null T cells are antigen specific and which are the precise antigens that trigger their expansion. It has been suggested that CD4+CD28null T lymphocytes are auto-reactive and that repeated stimulation by auto-antigens drives the expansion of this cell subset.Expansion of the CD4+CD28 null T-cell subset in patients affected by autoimmune disorders has been linked to the severity of disease and an unfavourable prognosis.
- Conditions
- Autoimmune Hemolytic Anemia
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start30 Jan 2023 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ehab Salah Eldin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711264
- Sponsor's protocol ID
- CD4+CD28- Lymphocyte IN AIHA
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26696796Youssef 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.
PubMed 32709527Fattizzo 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.
PubMed 31998632Jager 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.
PubMed 31839434Broux 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.
PubMed 22784556Thewissen 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.
PubMed 17982040
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Circulating CD4+CD28 Null T Helper Lymphocytes in Patients With Autoimmune Hemolytic Anemia.
- ClinicalTrials.gov ID
- NCT05711264
- Acronym / sponsor ID
- CD4+CD28- Lymphocyte IN AIHA
- Conditions
- Autoimmune Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary.
- Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.
Detailed description
Autoimmune hemolytic anemia (AIHA) has always been considered the simplest and most scholastic example of antibody-mediated autoimmune disease.It has been identified as a greatly heterogeneous disease, due to several immunological mechanisms involved beyond antibodies, complement and antibody-dependent cell-mediated cytotoxicity (ADCC). AIHAs may be Idiopathic of unknown cause Secondary associated with several conditions : (lymphoproliferative, autoimmune , infectious diseases, immunodeficiencies, solid tumors, transplants, and drugs).Several subsets of T and B lymphocytes with highly specialized functions have been characterized. Some lymphocytes promote inflammation, while others have anti-inflammatory roles, and an optimal balance between these two opposing sets of lymphocytes is critical for immune homeostasis. A pro-inflammatory subset of CD4+ T helper 1 (Th1) lymphocytes known as cluster of differentiation 4 positive 28 negative T helper lymphocytes (CD4+CD28 null T cells) because they characteristically lack CD28 which is a co-stimulatory receptor critical for the activation and function of T cells.CD4+CD28 null T cells are rare in healthy individuals, but they increase in inflammatory and immune-mediated diseases. Prevalence of CD4+CD28 null T cells is high in chronic inflammatory diseases, autoimmune diseases, immunodeficiency and specific infectious diseases.It remains controversial whether CD4+CD28null T cells are antigen specific and which are the precise antigens that trigger their expansion. It has been suggested that CD4+CD28null T lymphocytes are auto-reactive and that repeated stimulation by auto-antigens drives the expansion of this cell subset.Expansion of the CD4+CD28 null T-cell subset in patients affected by autoimmune disorders has been linked to the severity of disease and an unfavourable prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 1- newly diagnosed patients with AIHA 2- patients with idiopathic or secondary AIHA
Key exclusion criteria (1 listed)
- 1-current steroid therapy 2- other concurrent chronic inflammatory conditions 3-recent blood transfusion 4- active Hepatitis C virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Role of CD4+CD28 null T helper lymphocytes in monitoring response to therapy in AIHA using flowcytometry in serum of AIHA patients.
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 26696796Barcellini 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.
- Background: PubMed 32709527Youssef 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.
- Background: PubMed 31998632Fattizzo 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.
- Background: PubMed 31839434Jager 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.
- Background: PubMed 22784556Broux 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.
- Background: PubMed 17982040Thewissen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hemolytic Anemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira ehab (01005305860, amira.ehab99@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of CD4+CD28 null T helper lymphocytes in monitoring response to therapy in AIHA using flowcytometry in serum of AIHA patients. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711264, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.