Immune Thrombocytopenic PurpuraNCT05093257
Study of T Cells and Natural Killer Cells Expression in Patients With Immune Thrombocytopenic Purpura
An observational study of Immune Thrombocytopenic Purpura, run by Sohag University.
Trial summary
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). Read more about this study
- Who is it for?
- Ages 1 year to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- Laboratory investigations for patients
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2022
- 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 1 year to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Group I: age and sex matched healthy control individuals. Group II: available number of ITP patients.
Who may be able to join
- Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia according to bone marrow findings .
Who cannot join
- Other causes of thrombocytopenia as:
- Hypersplenism.
- Bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes.
- Cancer treatments like chemotherapy and radiation therapy.
- Exposure to toxic chemicals as arsenic and benzene.
- Medications to treat bacterial infections (antibiotics)and treat seizures or blood thinner heparin.
Trial locations and contacts
No sites are listed yet.
About this study
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs). Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP.NK cells can also modulate cellular immunity in ITP patients.
Read the detailed description
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L.ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs).Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. Auto-Abs production often occurs due to the loss of self-tolerance and increased stimulation of the immune system. The immune system includes a variety of B- and T cells which cooperate with each other in T-cell-dependent antibody production reactions and play significant roles in humoral and cellular immunity. Although the pathogenesis of ITP has not been clearly understood, the autoreactive B- and T cells have been directly and indirectly involved in Auto-Abs production, respectively. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP. It can be stated that CD4+ T cells are indirectly involved in ITP pathogenesis by inducing the increased activity of B cells during Auto-Abs production. Cytotoxic T lymphocytes (CTLs) are another subgroup of T lymphocytes characterized by the expression of CD8+ surface marker, destroying the pathogenic factors via granzyme and perforin production. These cells are increased in ITP patients and are involved in platelet destruction via augmented production of granzyme and perforin. NK cells can also modulate cellular immunity in ITP patients.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- Laboratory investigations for control, Laboratory investigations for patients
- Keywords
- T cells and NK cells in ITP patients
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory investigations for controlDiagnostic test
- Complete blood picture .
- Erythrocyte sedimentation rate(ESR).
- Liver function tests .
- Kidney function tests.
- CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry
Laboratory investigations for patientsDiagnostic test
- Complete blood picture .
- Erythrocyte sedimentation rate(ESR).
- Liver function tests .
- Kidney function tests.
- Anti-nuclear antibodies test by immunoflourescence for ITP patients.
- Bone marrow aspiration (for diagnosis of ITP).
- CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry.
| Study group | Role | What they receive |
|---|---|---|
| Group I | age and sex matched healthy control individuals. Receives: Diagnostic Test: Laboratory investigations for control | |
| Group II | available number of ITP patients. Receives: Diagnostic Test: Laboratory investigations for patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the percentages of CD4+ cells from peripheral blood samples by Flowcytometry
Methods of the study: All patients were subjected to:
- Full history taking.
- Laboratory investigations:
- Complete blood picture .
- Erythrocyte sedimentation rate(ESR).
- Liver function tests .
- Kidney function tests.
- Anti-nuclear antibodies test by immunofluorescence for ITP patients.
- Bone marrow aspiration (for diagnosis of ITP).
- CD3, CD4 from peripheral blood samples by Flowcytometry.
Measured: within 3 days after collection of samples.
Assessment the percentages of CD8+cells in ITP patients from peripheral blood samples by Flowcytometry .
Methods of the study: All patients were subjected to:
- Full history taking.
- Laboratory investigations:
- Complete blood picture .
- Erythrocyte sedimentation rate(ESR).
- Liver function tests .
- Kidney function tests.
- Anti-nuclear antibodies test by immunofluorescence for ITP patients.
- Bone marrow aspiration (for diagnosis of ITP).
- CD3, CD8 from peripheral blood samples by Flowcytometry.
Measured: within 3 days after collection of samples.
Assessment the percentages of NK(CD16 +, CD56 +) cells in ITP patients from peripheral blood samples by Flowcytometry .
Methods of the study: All patients were subjected to:
- Full history taking.
- Laboratory investigations:
- Complete blood picture .
- Erythrocyte sedimentation rate(ESR).
- Liver function tests .
- Kidney function tests.
- Anti-nuclear antibodies test by immunofluorescence for ITP patients.
- Bone marrow aspiration (for diagnosis of ITP).
- CD16, CD56 from peripheral blood samples by Flowcytometry.
Measured: within 3 days after collection of samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mostafa Hashem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093257
- Sponsor's protocol ID
- Soh-Med-21-10-12
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 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
- Study of T Cells and Natural Killer Cells Expression in Patients With Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT05093257
- Acronym / sponsor ID
- Soh-Med-21-10-12
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- T cells and NK cells in ITP patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Oct 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.
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs). Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP.NK cells can also modulate cellular immunity in ITP patients.
Detailed description
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L.ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs).Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. Auto-Abs production often occurs due to the loss of self-tolerance and increased stimulation of the immune system. The immune system includes a variety of B- and T cells which cooperate with each other in T-cell-dependent antibody production reactions and play significant roles in humoral and cellular immunity. Although the pathogenesis of ITP has not been clearly understood, the autoreactive B- and T cells have been directly and indirectly involved in Auto-Abs production, respectively. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP. It can be stated that CD4+ T cells are indirectly involved in ITP pathogenesis by inducing the increased activity of B cells during Auto-Abs production. Cytotoxic T lymphocytes (CTLs) are another subgroup of T lymphocytes characterized by the expression of CD8+ surface marker, destroying the pathogenic factors via granzyme and perforin production. These cells are increased in ITP patients and are involved in platelet destruction via augmented production of granzyme and perforin. NK cells can also modulate cellular immunity in ITP patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Laboratory investigations for controlage and sex matched healthy control individuals. |
| Group II | – | Diagnostic Test: Laboratory investigations for patientsavailable number of ITP patients. |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Group I: age and sex matched healthy control individuals. Group II: available number of ITP patients.
Key inclusion criteria (1 listed)
- Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia according to bone marrow findings .
Key exclusion criteria (6 listed)
- Other causes of thrombocytopenia as:
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 |
|---|---|---|
| Laboratory investigations for control1. Complete blood picture . 2. Erythrocyte sedimentation rate(ESR). 3. Liver function tests . 4. Kidney function tests. 5. CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry | Diagnostic test | Group I |
| Laboratory investigations for patients1. Complete blood picture . 2. Erythrocyte sedimentation rate(ESR). 3. Liver function tests . 4. Kidney function tests. 5. Anti-nuclear antibodies test by immunoflourescence for ITP patients. 6. Bone marrow aspiration (for diagnosis of ITP). 7. CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry. | Diagnostic test | Group II |
Primary outcome
Assessment the percentages of CD4+ cells from peripheral blood samples by Flowcytometry
Time frame: within 3 days after collection of samples.
Methods of the study: All patients were subjected to: 1. Full history taking. 2. Laboratory investigations: 1. Complete blood picture . 2. Erythrocyte sedimentation rate(ESR). 3. Liver function tests . 4. Kidney function tests. 5. Anti-nuclear antibodies test by immunofluorescence for ITP patients. 6. Bone marrow aspiration (for diagnosis of ITP). 7. CD3, CD4 from peripheral blood samples by Flowcytometry.
Assessment the percentages of CD8+cells in ITP patients from peripheral blood samples by Flowcytometry .
Time frame: within 3 days after collection of samples.
Methods of the study: All patients were subjected to: 1. Full history taking. 2. Laboratory investigations: 1. Complete blood picture . 2. Erythrocyte sedimentation rate(ESR). 3. Liver function tests . 4. Kidney function tests. 5. Anti-nuclear antibodies test by immunofluorescence for ITP patients. 6. Bone marrow aspiration (for diagnosis of ITP). 7. CD3, CD8 from peripheral blood samples by Flowcytometry.
Assessment the percentages of NK(CD16 +, CD56 +) cells in ITP patients from peripheral blood samples by Flowcytometry .
Time frame: within 3 days after collection of samples.
Methods of the study: All patients were subjected to: 1. Full history taking. 2. Laboratory investigations: 1. Complete blood picture . 2. Erythrocyte sedimentation rate(ESR). 3. Liver function tests . 4. Kidney function tests. 5. Anti-nuclear antibodies test by immunofluorescence for ITP patients. 6. Bone marrow aspiration (for diagnosis of ITP). 7. CD16, CD56 from peripheral blood samples by Flowcytometry.
Results and safety
Results are not available in the source record.
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenic Purpura, run by Sohag 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 6 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara M Hashem (01024758746, sara011095@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the percentages of CD4+ cells from peripheral blood samples by Flowcytometry (time frame: within 3 days after collection of samples.). The study lists 3 primary outcomes in all. 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.