Autoimmune Hemolytic AnemiafhfrNCT04814394
The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia Before and After Tratment
An observational study of Autoimmune Hemolytic Anemia, run by Assiut University.
Trial summary
we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- flowcytometry
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sample size is 50 (25 in each arm) but number of controls will be decreased and number of cases will be increased
Who may be able to join
- Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment
Who cannot join
- Pregnancy or breast-feeding women
- Patients treated with corticoids or immunosuppressant.
- Patients with hematological malignance.
- Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients
About this study
Official title: The Significance of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia
we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.
Read the detailed description
Autoimmune hemolytic anemia (AIHA) is an acquired autoimmune disease resulting in the production of antibodies directed against the patient's red blood cells (RBCs) causing shortened erythrocyte lifespan.
The main pathogensis of the disease is autoantibodies (Ab) that directed against erythrocytes, with or without complement (C) activation. The most common form of AIHA is warm AIHA characterized by the presence of warm-type autoantibodies-immunoglobulin G (IgG) which reacts optimally at 37 °C, causing RBC extravascular destruction by tissue macrophages .
Previous studies of the etiology and pathogenesis of AIHA have focused on the autoreactive B cells that have escaped tolerance mechanisms and regulatory T cells (Treg).
The main treatment of AIHA includes RBC transfusion and immune system inhibitors such as corticosteroids. During an immune response, CD4 Th cells can differentiate into several unique effector lineages that promote different immune responses via the secretion of distinct types of cytokines.
T follicular helper (Tfh) cells are a CD4 T cell lineage whose major function is to help B cells form germinal centers (GCs) and produce high-affinity antibodies(6). Tfh cells are characterized by expression of the CXCR5, the transcriptional repressor B cell lymphoma 6 (Bcl-6), programmed death 1 (PD-1), and inducible costimulator (ICOS).
Follicular regulatory T (Tfr) cells are a newly identified subset of Treg cells that coexpress markers of both Treg cells and Tfh cells. In addition to expressing Tfh-related markers, Tfr cells also express regulatory markers, such as FoxP3, CD25, CTLA-4, IL-10, and transforming growth factor β (TGFβ).
TFR cells represent a highly specialized subpopulation of Foxp3+ Tregs that co-express TFHfeatures, such as Bcl-6, CXCR5, ICOS, PD-1 and Treg features CD25 and Foxp3. TFR cells have the ability to inhibit TFH activation and cytokines production and suppress B cell GL7 and B7-1 expression and limited class switch recombination occurring in the GC via high expression of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and production of inhibitory cytokine- interleukin 10 (IL-10) and transforming growth factorβ (TGFβ)(5). The involvement of TFR cells in the pathogenesis of human autoimmune diseases remains speculative, but an alteration of the TFR:TFH ratio is observed in the blood of patients suffering from several autoimmune diseases, such as child immune thrombocytopenia, and rheumatoid arthritis.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- flowcytometry
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flowcytometryDiagnostic test
The study of CD4,CD25,FOXP3 and PD-1 on peripheral blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of circulating T-follicular helper and T-follicular regulatory in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after treatment
Measured: Baseline
Secondary outcomes (1)
Measure the ratio between the T- follicular helper and T-follicular regulatory
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Apr 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814394
- Sponsor's protocol ID
- fhraha
- Acronym
- fhfr
- Status last verified
- Oct 2021
- First submitted
- 22 Mar 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Significance of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia
- ClinicalTrials.gov ID
- NCT04814394
- Acronym / sponsor ID
- fhfr / fhraha
- Conditions
- Autoimmune Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Mar 2021 (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.
we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.
Detailed description
Autoimmune hemolytic anemia (AIHA) is an acquired autoimmune disease resulting in the production of antibodies directed against the patient's red blood cells (RBCs) causing shortened erythrocyte lifespan.
The main pathogensis of the disease is autoantibodies (Ab) that directed against erythrocytes, with or without complement (C) activation. The most common form of AIHA is warm AIHA characterized by the presence of warm-type autoantibodies-immunoglobulin G (IgG) which reacts optimally at 37 °C, causing RBC extravascular destruction by tissue macrophages .
Previous studies of the etiology and pathogenesis of AIHA have focused on the autoreactive B cells that have escaped tolerance mechanisms and regulatory T cells (Treg).
The main treatment of AIHA includes RBC transfusion and immune system inhibitors such as corticosteroids. During an immune response, CD4 Th cells can differentiate into several unique effector lineages that promote different immune responses via the secretion of distinct types of cytokines.
T follicular helper (Tfh) cells are a CD4 T cell lineage whose major function is to help B cells form germinal centers (GCs) and produce high-affinity antibodies(6). Tfh cells are characterized by expression of the CXCR5, the transcriptional repressor B cell lymphoma 6 (Bcl-6), programmed death 1 (PD-1), and inducible costimulator (ICOS).
Follicular regulatory T (Tfr) cells are a newly identified subset of Treg cells that coexpress markers of both Treg cells and Tfh cells. In addition to expressing Tfh-related markers, Tfr cells also express regulatory markers, such as FoxP3, CD25, CTLA-4, IL-10, and transforming growth factor β (TGFβ).
TFR cells represent a highly specialized subpopulation of Foxp3+ Tregs that co-express TFHfeatures, such as Bcl-6, CXCR5, ICOS, PD-1 and Treg features CD25 and Foxp3. TFR cells have the ability to inhibit TFH activation and cytokines production and suppress B cell GL7 and B7-1 expression and limited class switch recombination occurring in the GC via high expression of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and production of inhibitory cytokine- interleukin 10 (IL-10) and transforming growth factorβ (TGFβ)(5). The involvement of TFR cells in the pathogenesis of human autoimmune diseases remains speculative, but an alteration of the TFR:TFH ratio is observed in the blood of patients suffering from several autoimmune diseases, such as child immune thrombocytopenia, and rheumatoid arthritis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample size is 50 (25 in each arm) but number of controls will be decreased and number of cases will be increased
Key inclusion criteria (1 listed)
- Patients diagnosed as autoimmune hemolytic anemia, primary or secondary, male or female, any age but not on treatment
Key exclusion criteria (4 listed)
- Pregnancy or breast-feeding women
- Patients treated with corticoids or immunosuppressant.
- Patients with hematological malignance.
- Patients with alloimmune hemolytic anemia as ABO incompatibility or transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flowcytometryThe study of CD4,CD25,FOXP3 and PD-1 on peripheral blood sample | Diagnostic test | – |
Primary outcome
The proportion of circulating T-follicular helper and T-follicular regulatory in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after treatment
Time frame: Baseline
1 secondary outcome
Measure the ratio between the T- follicular helper and T-follicular regulatory
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 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: opening soon, as of the sponsor's last update on 26 Oct 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of circulating T-follicular helper and T-follicular regulatory in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after treatment (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2021.