Immune ThrombocytopeniaNCT06715215
Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia
A study testing Acute phase proteins in people with Immune Thrombocytopenia, run by Sohag University at 1 site in Egypt.
Trial summary
Immune thrombocytopenia (ITP) are antibody-mediated disorders in which platelets are destroyed mainly through activating immunoglobulin (IgG) Fc receptors on phagocytes in the spleen and liver, eventually resulting in thrombocytopenia Acute phase proteins (APP) are inflammation markers that exhibit significant changes… 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 Thrombocytopenia
- What is being tested?
- Acute phase proteins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 30 Dec 2026
- Phase
- Interventional
- 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 1 year to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia by bone marrow findings .
- Age of patients : from 1 year to 50 years.
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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eman H Ali, Assistant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university hospital
Sohag, Sahag
Magdy M Ameen, Professor
About this study
Immune thrombocytopenia (ITP) are antibody-mediated disorders in which platelets are destroyed mainly through activating immunoglobulin (IgG) Fc receptors on phagocytes in the spleen and liver, eventually resulting in thrombocytopenia Acute phase proteins (APP) are inflammation markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Acute phase reactants can be classified as positive or negative, depending on their serum concentrations during inflammation. Positive acute phase reactants are upregulated, and their concentrations increase during inflammation. Negative acute phase reactants are downregulated, and their concentrations decrease during inflammation. Positive acute phase proteins include procalcitonin, C-reactive protein, ferritin, fibrinogen, hepcidin, and serum amyloid A. Negative acute phase reactants include albumin, prealbumin, transferrin, retinol-binding protein, and antithrombin CRP is now well established as a major acute phase protein and is used in daily clinical practice as a sensitive biomarker for infection and inflammation, with its level increasing from <0.05 to >500 mg/L after acute infections. CRP is produced by hepatocytes, in response to inflammatory cytokines such as interleukin (IL)-6 and IL-1, with serum concentrations rising to >5 mg/L after 6 hours and peaking after ∼48 hours. In healthy young adult volunteer blood donors, the median concentration of CRP was found to be ∼0.8 mg/L CRP levels are useful as a clinical diagnostic tool for infection, and it is a common knowledge that ITP is triggered by viral infection that precedes the clinical picture of ITP by a few days to a few weeks Procalcitonin (PCT) is used as a reliable inflammatory biomarker with high sensitivity and specificity ferritin was confirmed as an inflammation and infection biomarker in the diagnosis of viral and bacterial infections.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Acute phase proteins
- 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.
Acute phase proteinsDiagnostic test
Assessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia
| Study group | Role | What they receive |
|---|---|---|
| age and sex matched thrombocytopenic patients other than ITP. | Active comparator | Causes of decreased platelets count other than immune thrombocytopenia Receives: Diagnostic Test: Acute phase proteins |
| acute ITP patients | Active comparator | Patients diagnosed as acute thrombocytopenia Receives: Diagnostic Test: Acute phase proteins |
| chronic ITP patients . | Active comparator | Patients diagnosed as chronic thrombocytopenia Receives: Diagnostic Test: Acute phase proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute phase proteins
By taking serum samples from pateints and measure acute phase proteins levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Nov 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mohamed Abdelhameed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715215
- Sponsor's protocol ID
- Soh-Med-24-11-13MS
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gruys E, Toussaint MJ, Niewold TA, Koopmans SJ. Acute phase reaction and acute phase proteins. J Zhejiang Univ Sci B. 2005 Nov;6(11):1045-56. doi: 10.1631/jzus.2005.B1045.
PubMed 16252337Zeller B, Rajantie J, Hedlund-Treutiger I, Tedgard U, Wesenberg F, Jonsson OG, Henter JI; NOPHO ITP. Childhood idiopathic thrombocytopenic purpura in the Nordic countries: epidemiology and predictors of chronic disease. Acta Paediatr. 2005 Feb;94(2):178-84. doi: 10.1111/j.1651-2227.2005.tb01887.x.
PubMed 15981751Semple JW, Italiano JE Jr, Freedman J. Platelets and the immune continuum. Nat Rev Immunol. 2011 Apr;11(4):264-74. doi: 10.1038/nri2956.
PubMed 21436837Sullivan PS, Hanson DL, Chu SY, Jones JL, Ciesielski CA. Surveillance for thrombocytopenia in persons infected with HIV: results from the multistate Adult and Adolescent Spectrum of Disease Project. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Apr 1;14(4):374-9. doi: 10.1097/00042560-199704010-00011.
PubMed 9111481
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Acute Phase Proteins In Diagnosis of Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06715215
- Acronym / sponsor ID
- Soh-Med-24-11-13MS
- Conditions
- Immune Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Dec 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.
Immune thrombocytopenia (ITP) are antibody-mediated disorders in which platelets are destroyed mainly through activating immunoglobulin (IgG) Fc receptors on phagocytes in the spleen and liver, eventually resulting in thrombocytopenia Acute phase proteins (APP) are inflammation markers that exhibit significant changes in serum concentration during inflammation. These are also important mediators produced in the liver during acute and chronic inflammatory states. Acute phase reactants can be classified as positive or negative, depending on their serum concentrations during inflammation. Positive acute phase reactants are upregulated, and their concentrations increase during inflammation. Negative acute phase reactants are downregulated, and their concentrations decrease during inflammation. Positive acute phase proteins include procalcitonin, C-reactive protein, ferritin, fibrinogen, hepcidin, and serum amyloid A. Negative acute phase reactants include albumin, prealbumin, transferrin, retinol-binding protein, and antithrombin CRP is now well established as a major acute phase protein and is used in daily clinical practice as a sensitive biomarker for infection and inflammation, with its level increasing from <0.05 to >500 mg/L after acute infections. CRP is produced by hepatocytes, in response to inflammatory cytokines such as interleukin (IL)-6 and IL-1, with serum concentrations rising to >5 mg/L after 6 hours and peaking after ∼48 hours. In healthy young adult volunteer blood donors, the median concentration of CRP was found to be ∼0.8 mg/L CRP levels are useful as a clinical diagnostic tool for infection, and it is a common knowledge that ITP is triggered by viral infection that precedes the clinical picture of ITP by a few days to a few weeks Procalcitonin (PCT) is used as a reliable inflammatory biomarker with high sensitivity and specificity ferritin was confirmed as an inflammation and infection biomarker in the diagnosis of viral and bacterial infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| age and sex matched thrombocytopenic patients other than ITP. | Active comparator | Diagnostic Test: Acute phase proteinsCauses of decreased platelets count other than immune thrombocytopenia |
| acute ITP patients | Active comparator | Diagnostic Test: Acute phase proteinsPatients diagnosed as acute thrombocytopenia |
| chronic ITP patients . | Active comparator | Diagnostic Test: Acute phase proteinsPatients diagnosed as chronic thrombocytopenia |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia by bone marrow findings .
- Age of patients : from 1 year to 50 years.
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 |
|---|---|---|
| Acute phase proteinsAssessment of acute phase proteins levels in patients diagnosed with immune thrombocytopenia | Diagnostic test | acute ITP patients, age and sex matched thrombocytopenic patients other than ITP., chronic ITP patients . |
Primary outcome
Acute phase proteins
Time frame: 2 years
By taking serum samples from pateints and measure acute phase proteins levels
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 4 Dec 2024.
- Background: PubMed 16252337Gruys E, Toussaint MJ, Niewold TA, Koopmans SJ. Acute phase reaction and acute phase proteins. J Zhejiang Univ Sci B. 2005 Nov;6(11):1045-56. doi: 10.1631/jzus.2005.B1045.
- Background: PubMed 15981751Zeller B, Rajantie J, Hedlund-Treutiger I, Tedgard U, Wesenberg F, Jonsson OG, Henter JI; NOPHO ITP. Childhood idiopathic thrombocytopenic purpura in the Nordic countries: epidemiology and predictors of chronic disease. Acta Paediatr. 2005 Feb;94(2):178-84. doi: 10.1111/j.1651-2227.2005.tb01887.x.
- Background: PubMed 21436837Semple JW, Italiano JE Jr, Freedman J. Platelets and the immune continuum. Nat Rev Immunol. 2011 Apr;11(4):264-74. doi: 10.1038/nri2956.
- Background: PubMed 9111481Sullivan PS, Hanson DL, Chu SY, Jones JL, Ciesielski CA. Surveillance for thrombocytopenia in persons infected with HIV: results from the multistate Adult and Adolescent Spectrum of Disease Project. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Apr 1;14(4):374-9. doi: 10.1097/00042560-199704010-00011.
- Individual participant dataSharing planned: Undecided
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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.
Eman H Ali, Assistant Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute phase proteins in people with Immune Thrombocytopenia, run by Sohag University at 1 site in Egypt.
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 2 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Rana M Abd Elhameed, Resident (01070198923, rana_mohamed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute phase proteins (time frame: 2 years). 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 NCT06715215, which also lists 4 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 4 Dec 2024.