Primary Immunodeficiency Diseases (PID)NCT06649643
Inbon Errors of Immunity Attending Assiut University Children&Amp;#39;s Hospital: a Single Center Study
An observational study of Primary Immunodeficiency Diseases (PID), run by Assiut University.
Trial summary
Aim of Study The aim of this study to describe the clinical profile of children diagnosed as IEIs who were admitted to in Assiut university children\'s Hospital. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- Inborn errors of immunity and A. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1-Immunoglobulins IgG, IgM, IgA, IgE 2-Flow cytometric assessment: B
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2025to 5 Mar 2026
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Sex- all Age - maximum age 18 y
Who may be able to join
None listed.
Who cannot join
- patients without any criteria of ten warning signs
Trial locations and contacts
No sites are listed yet.
Christeena Goda Hakeem, Resident of Pediatrics contact
About this study
Aim of Study The aim of this study to describe the clinical profile of children diagnosed as IEIs who were admitted to in Assiut university children\'s Hospital.
Read the detailed description
Introduction
Inborn errors of immunity (IEIs) are generally considered to be rare monogenic disorders of the immune system that cause immunodeficiency, autoinflammation, autoimmunity, allergy and/or cancer (1). IEIs are a group of diseases comprised of more than 450 IEIs, and they are becoming more prevalent (2). Although IEIs are rare diseases, they are more common than previously thought, following the use of modern diagnostic methods. A recent evaluation indicated that at least 1-2% of the world's population are affected by IEIs (3). Several warning signs have been developed to increase physician awareness about the early signs that can help to diagnosis IEIs. Warning signs of IEIs were developed by an institution called the Jeffrey Modell Foundation (JMF) (4,5). the ten warning signs are four or more new ear infections within 1 year,two or more serious sinus infections within 1 year,two or more months on antibiotics with little effect,two or more pneumonias within 1 year,failure of an infant to gain weight or grow normally,recurrent, deep skin or organ abscesses, persistent thrush in mouth or fungal infection on skin, need for intravenous antibiotics to clear infections,Two or more deep-seated infections including septicemia and family history of IEIs. (6). The International Union of Immunological Societies (IUIS) has classified IEIs into nine categories based upon the segment of the immune system that is affected, plus a 10th category of IEIs phenocopies. Each category is characterized by unique types of infections and clinical features that are useful for the selection of initial appropriate laboratory evaluation to help with diagnosis (7). The mechanisms that explain the increased susceptibility of IEIs patients to the development of tumours are multiple and different in the various pathologies. The most common process is the reduction of cell-mediated immunosurveillance, which plays a fundamental role in protecting against tumours (8,9). Several pathways, such as genomic instability, overstimulation of immune cells, viral infection and chronic inflammation, have been proposed to explain the increased incidence of malignancy among patients with IEIs (10). Moreover, defective dendritic cells (DCs) differentiation and function, which affect the initiation and development of T cell responses, have been associated with cancer development (11) The diagnostic investigation of IEIs should be guided by the clinical characterization of patients, aiming to optimize the use of complementary tests. Many diagnoses are attained only through genetic tests, which are not always available. However, the absence of a diagnosis of certainty should never delay the implementation of therapeutic measures that preserve patient life and health (12). Major advances in the treatment of these disorders have occurred over the last half-century, and deeper molecular understanding of many disorders combined with clinically available genetic testing is allowing for use of precision therapy for several IEIs. Patients with antibody deficiencies who rely on immunoglobulin replacement therapy now have many treatment options with products that are much safer and better tolerated compared to the past (13). Steroids are often used as an initial therapy but have serious long-term complications. Targeted immune therapies, such as cytokine or small molecule inhibitors, are increasingly available with the advantage of fewer global immune suppressive effects. However, patients with IEIs often do not have an adequate clinical response to immunosuppressive treatment, resulting in referral for allogeneic hematopoietic cell transplantation (HCT) as a potentially curative therapy (14,15).
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- Inborn errors of immunity, A. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1-Immunoglobulins IgG, IgM, IgA, IgE 2-Flow cytometric assessment: B
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inborn errors of immunityDiagnostic test
- Routine
.1CBC with blood film.
.2Liver Function Test.
.3Kidney Function Test.
- Inflamatory marker ESR, CRP
B.Immunology
- Immunoglobulins IgG, IgM, IgA, IgE
- Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) anc NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM)
- Chest x-ray to assess thymus and any abnormality
- DHR123 whenever needed (e.g. chronic granulomatous disease).
- LAD panel (CD11b CD15-CD18) whenever needed.
- Complement assay (CH
A. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1-Immunoglobulins IgG, IgM, IgA, IgE 2-Flow cytometric assessment: BDiagnostic test
- Routine
.1CBC with blood film.
.2Liver Function Test.
.3Kidney Function Test.
- Inflamatory marker ESR, CRP
B.Immunology
- Immunoglobulins IgG, IgM, IgA, IgE
- Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) anc NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM)
- Chest x-ray to assess thymus and any abnormality
- DHR123 whenever needed (e.g. chronic granulomatous disease).
- LAD panel (CD11b CD15-CD18) whenever needed.
- Complement assay (CH
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Patients with Inborn Errors of Immunity in Assiut University Children Hospital: Single Center Study
Warning signs for early diagnosis
- Weight in kilogram
- Height in meters investigation --Routine
- CBC with blood film.
- Liver Function Test.
- Kidney Function Test.
- Inflammatory marker ESR,CRP --Immunology
- Immunoglobulins IgG, IgM, IgA, IgE
- Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) and NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM)
- Chest x-ray to assess thymus and any abnormality
- DHR123 whenever needed (e.g. chronic granulomatous disease).
- LAD panel ( CD11b CD15- CD18) whenever needed. .Complement assay (CH 50,C3,C4) whenever needed .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start5 Jan 2025 (estimated)
- Primary completion5 Jan 2026 (estimated)
- Study completion5 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christeena Goda Hakeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649643
- Sponsor's protocol ID
- IEIs of Assuit hospital
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tangye SG, Al-Herz W, Bousfiha A, Chatila T, Cunningham-Rundles C, Etzioni A, Franco JL, Holland SM, Klein C, Morio T, Ochs HD, Oksenhendler E, Picard C, Puck J, Torgerson TR, Casanova JL, Sullivan KE. Correction to: Human Inborn Errors of Immunity: 2019 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2020 Jan;40(1):65. doi: 10.1007/s10875-020-00763-0.
PubMed 32086639Tangye SG, Al-Herz W, Bousfiha A, Cunningham-Rundles C, Franco JL, Holland SM, Klein C, Morio T, Oksenhendler E, Picard C, Puel A, Puck J, Seppanen MRJ, Somech R, Su HC, Sullivan KE, Torgerson TR, Meyts I. Human Inborn Errors of Immunity: 2022 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2022 Oct;42(7):1473-1507. doi: 10.1007/s10875-022-01289-3. Epub 2022 Jun 24.
PubMed 35748970
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inbon Errors of Immunity Attending Assiut University Children&Amp;#39;s Hospital: a Single Center Study
- ClinicalTrials.gov ID
- NCT06649643
- Acronym / sponsor ID
- IEIs of Assuit hospital
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 5 Jan 2026 (estimated)
- Study completion
- 5 Mar 2026 (estimated)
- First posted
- 21 Oct 2024 (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.
Aim of Study The aim of this study to describe the clinical profile of children diagnosed as IEIs who were admitted to in Assiut university children\'s Hospital.
Detailed description
Introduction
Inborn errors of immunity (IEIs) are generally considered to be rare monogenic disorders of the immune system that cause immunodeficiency, autoinflammation, autoimmunity, allergy and/or cancer (1). IEIs are a group of diseases comprised of more than 450 IEIs, and they are becoming more prevalent (2). Although IEIs are rare diseases, they are more common than previously thought, following the use of modern diagnostic methods. A recent evaluation indicated that at least 1-2% of the world's population are affected by IEIs (3). Several warning signs have been developed to increase physician awareness about the early signs that can help to diagnosis IEIs. Warning signs of IEIs were developed by an institution called the Jeffrey Modell Foundation (JMF) (4,5). the ten warning signs are four or more new ear infections within 1 year,two or more serious sinus infections within 1 year,two or more months on antibiotics with little effect,two or more pneumonias within 1 year,failure of an infant to gain weight or grow normally,recurrent, deep skin or organ abscesses, persistent thrush in mouth or fungal infection on skin, need for intravenous antibiotics to clear infections,Two or more deep-seated infections including septicemia and family history of IEIs. (6). The International Union of Immunological Societies (IUIS) has classified IEIs into nine categories based upon the segment of the immune system that is affected, plus a 10th category of IEIs phenocopies. Each category is characterized by unique types of infections and clinical features that are useful for the selection of initial appropriate laboratory evaluation to help with diagnosis (7). The mechanisms that explain the increased susceptibility of IEIs patients to the development of tumours are multiple and different in the various pathologies. The most common process is the reduction of cell-mediated immunosurveillance, which plays a fundamental role in protecting against tumours (8,9). Several pathways, such as genomic instability, overstimulation of immune cells, viral infection and chronic inflammation, have been proposed to explain the increased incidence of malignancy among patients with IEIs (10). Moreover, defective dendritic cells (DCs) differentiation and function, which affect the initiation and development of T cell responses, have been associated with cancer development (11) The diagnostic investigation of IEIs should be guided by the clinical characterization of patients, aiming to optimize the use of complementary tests. Many diagnoses are attained only through genetic tests, which are not always available. However, the absence of a diagnosis of certainty should never delay the implementation of therapeutic measures that preserve patient life and health (12). Major advances in the treatment of these disorders have occurred over the last half-century, and deeper molecular understanding of many disorders combined with clinically available genetic testing is allowing for use of precision therapy for several IEIs. Patients with antibody deficiencies who rely on immunoglobulin replacement therapy now have many treatment options with products that are much safer and better tolerated compared to the past (13). Steroids are often used as an initial therapy but have serious long-term complications. Targeted immune therapies, such as cytokine or small molecule inhibitors, are increasingly available with the advantage of fewer global immune suppressive effects. However, patients with IEIs often do not have an adequate clinical response to immunosuppressive treatment, resulting in referral for allogeneic hematopoietic cell transplantation (HCT) as a potentially curative therapy (14,15).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sex- all Age - maximum age 18 y
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- patients without any criteria of ten warning signs
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 |
|---|---|---|
| Inborn errors of immunityA. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1. Immunoglobulins IgG, IgM, IgA, IgE 2. Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) anc NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM) 3. Chest x-ray to assess thymus and any abnormality 4. DHR123 whenever needed (e.g. chronic granulomatous disease). 5. LAD panel (CD11b CD15-CD18) whenever needed. 6. Complement assay (CH | Diagnostic test | – |
| A. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1-Immunoglobulins IgG, IgM, IgA, IgE 2-Flow cytometric assessment: BA. Routine .1CBC with blood film. .2Liver Function Test. .3Kidney Function Test. 4. Inflamatory marker ESR, CRP B.Immunology 1. Immunoglobulins IgG, IgM, IgA, IgE 2. Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) anc NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM) 3. Chest x-ray to assess thymus and any abnormality 4. DHR123 whenever needed (e.g. chronic granulomatous disease). 5. LAD panel (CD11b CD15-CD18) whenever needed. 6. Complement assay (CH | Diagnostic test | – |
Primary outcome
Profile of Patients with Inborn Errors of Immunity in Assiut University Children Hospital: Single Center Study
Time frame: Baseline
Warning signs for early diagnosis * Weight in kilogram * Height in meters investigation --Routine * CBC with blood film. * Liver Function Test. * Kidney Function Test. * Inflammatory marker ESR,CRP --Immunology * Immunoglobulins IgG, IgM, IgA, IgE * Flow cytometric assessment: B Cell (CD19), T cells (CD3,CD4, CD8) and NK Cells (CD16+56) and other markers whenever needed (e.g. CD40, CD40L for cases of hyper IGM) * Chest x-ray to assess thymus and any abnormality * DHR123 whenever needed (e.g. chronic granulomatous disease). * LAD panel ( CD11b CD15- CD18) whenever needed. .Complement assay (CH 50,C3,C4) whenever needed .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Results publication: PubMed 32086639Tangye SG, Al-Herz W, Bousfiha A, Chatila T, Cunningham-Rundles C, Etzioni A, Franco JL, Holland SM, Klein C, Morio T, Ochs HD, Oksenhendler E, Picard C, Puck J, Torgerson TR, Casanova JL, Sullivan KE. Correction to: Human Inborn Errors of Immunity: 2019 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2020 Jan;40(1):65. doi: 10.1007/s10875-020-00763-0.
- Results publication: PubMed 35748970Tangye SG, Al-Herz W, Bousfiha A, Cunningham-Rundles C, Franco JL, Holland SM, Klein C, Morio T, Oksenhendler E, Picard C, Puel A, Puck J, Seppanen MRJ, Somech R, Su HC, Sullivan KE, Torgerson TR, Meyts I. Human Inborn Errors of Immunity: 2022 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2022 Oct;42(7):1473-1507. doi: 10.1007/s10875-022-01289-3. Epub 2022 Jun 24.
- Individual participant dataSharing planned: No
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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.
Christeena Goda Hakeem, Resident of Pediatrics contact
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases (PID), 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 0 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 21 Oct 2024. 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 Christeena Goda Hakeem, Resident of Pediatrics (01271711547 ext. 01271711547, madonaj985@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Patients with Inborn Errors of Immunity in Assiut University Children Hospital: Single Center Study (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 NCT06649643, which also lists 2 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 21 Oct 2024.