Primary Immune ThrombocytopeniamicroRNAITPNCT05371743
Plasma microRNA Levels and Some Cytokines Expression in Patients With ITP Primary Immune Thrombocytopenic Purpura (ITP)
An observational study of Primary Immune Thrombocytopenia, run by Sohag University at 1 site in Egypt.
Trial summary
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by low platelet counts with or without mucocutaneous bleeding (McMillan, 2007). Like the majority of autoimmune diseases, ITP is an organ-specific disease, and abnormalities in the regulation of the immune system have been shown to play an important… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- Plasma RNA isolation, qPCR analysis of micro RNA, estimation of serum level of IL2 and estimation of serum level of IL17
- Type of treatment
- Vaccines
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Sep 2023
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a cross-sectional study. Patients will be recruited from the internal department- hematology unit outpatient clinic of El Minia University Hospital in collaboration with the clinical pathology department El Minia University Hospital and the biochemistry department of Minia and Sohag University. Research Ethics Medical Review Board of El-Minia University has approved the protocol.
Who may be able to join
- ITP patients
Who cannot join
- 1- Secondary causes of ITP as systemic lupus erythematosus (SLE), viral infections (HIV, hepatitis B or C infections) 2- Other underlying medical diseases that may cause thrombocytopenia as:
- malignancy
- megaloblastic anemia
- aplastic anemia
- lymphoproliferative disorders
- liver disease
- renal impairment
- pregnancy 3-Organomegally and/or lymphadenopathy. 4-Recent history of vaccination. 5-Recent evidence of bacterial infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82733
N S Shafik, lecture, 01067261504 ext. 02, nohasaber@med.sohag.edu.eg
M M Abd El Rhman, lecturer, 01021025859 ext. 02, monamohamed@med.sohag.edu.eg
About this study
Official title: Plasma microRNA Levels and Some Cytokines Expression in Patients With Primary Immune Thrombocytopenic Purpura (ITP)
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by low platelet counts with or without mucocutaneous bleeding (McMillan, 2007). Like the majority of autoimmune diseases, ITP is an organ-specific disease, and abnormalities in the regulation of the immune system have been shown to play an important role in the initiation and/or perpetuation of the disease (McKenzie et al.,2013).
Still, immune thrombocytopenia (ITP) is a significant clinical problem due to chronicity, treatment cost, occurrence mainly in, young, and relatively poorer quality of life
Read the detailed description
In recent years the critical role of miRNAs has been established in many diseases, including autoimmune disorders. Immune thrombocytopenic purpura (ITP) is a predominant autoimmune disease, in which aberrant expression of miRNAs has been observed, suggesting that miRNAs are involved in its development (Jafarzadeh et al., 2021). Studies have also shown that cell-free miRNAs in circulation are stable and that such miRNAs may be exploited as novel disease markers (Etheridge et al.,2011) and ( van Rooij et al., 2008).
MicroRNAs (miRNAs) are endogenous small RNAs, usually 18-25 nucleotides in length. These non-coding RNAs regulate gene expression by several mechanisms, such as repressing protein translation and altering mRNA stability (Ambros, 2008. Bartel,2004). In humans, >2,000 miRNAs have been discovered. The functional significance of the majority of the identified miRNAs has yet to be fully elucidated. Studies have shown that miRNAs play important roles in hematopoietic differentiation, e. g. megakaryocytopoiesis. (Garzon et al., 2008) and erythropoiesis ( Masaki et al., 2007 )and (Bruchovaetal., 2007), and in hematological malignancies (Rossi et al.,2010) and (Visone et al.,2009). More recently, miRNAs have also been implicated in cellular immune responses that contribute to ITP (Jernas et al., 2013) and (McKenzie etal., 2013). It was found that 23 differentially expressed miRNAs in ITP (14 up-regulated and 9 down-regulated) Altered miRNA expression may occur in specific diseases and at specific disease stages (Martin et al., 2012) Also, Recent studies have demonstrated that Th17, which is characterized for its production of IL-17, is elevated in ITP patients (Hu et al., 2012) and (Huber et al., 2007). IL-17 belongs to the IL-17 cytokine family. Increased IL-17 expression has been observed in various autoimmune diseases, such as rheumatoid arthritis (RA) ( Roeleveld et al., 2013) and systemic lupus erythematosus (SLE) (Ballantine et al., 2014). This evidence suggests that IL-17 may be associated with autoimmune diseases.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- Plasma RNA isolation, qPCR analysis of micro RNA, estimation of serum level of IL2, estimation of serum level of IL17
- Keywords
- MicroRNA, ITP, IL17
- 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.
Plasma RNA isolation, qPCR analysis of micro RNADiagnostic test
qPCR will be performed using Taqman microRNA assays (Applied Biosystems, Foster City, CA, USA) according to the manufacturer's protocol. Total RNAs going to be used to make cDNAs using TaqMan microRNA RT Kit. Diluted cDNAs were mixed with TaqMan Universal PCR Master Mix (No AmpErase UNG). Taqman miRNA assay will run in the 7500 Real-Time PCR System (Applied Biosystems). miR-39 also will be used as an exogenous control. All assays will be done in triplicates. The expression levels will be evaluated using the comparative cycle threshold (∆∆_Ct) method
estimation of serum level of IL2Diagnostic test
2ml of patient serum will be used to measure IL 2 in patients with different groups by ELISA technique.
The techniques will be done in the central research laboratory in Sohag university hospital
estimation of serum level of IL17Diagnostic test
2ml of patient serum will be used to measure IL17 in patients with different groups by ELISA technique.
The techniques will be done in the central research laboratory in Sohag university hospital
| Study group | Role | What they receive |
|---|---|---|
| ITP patients | Patients will be recruited from the internal department- hematology unit outpatient clinic of El Minia University Hospital in collaboration with the clinical pathology department of El Minia University Hospital and the biochemistry department of Minia and Sohag University. Exclusion criteria:
1. Secondary causes of ITP as systemic lupus erythematous (SLE), viral infections (HIV, hepatitis B or C infections)
2. Other underlying medical diseases that may cause thrombocytopenia as:
* malignancy
* megaloblastic anemia
* aplastic anemia
* lymphoproliferative disorders
* liver disease
* renal impairment
* pregnancy
3. Organomegally and/or lymphadenopathy.
4. Recent history of vaccination.
5. Recent evidence of bacterial infection. Receives: Diagnostic Test: Plasma RNA isolation, qPCR analysis of micro RNA; Diagnostic Test: estimation of serum level of IL2; Diagnostic Test: estimation of serum level of IL17 | |
| normal individuals | Blood samples will be taken from normal individuals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of some plasma miRNA profiling in primary ITP and correlation to disease phases and their possible roles in pathogenesis of ITP
Measurement of Micro RNA by qPCR
Measured: 1 May 2022 to 1 September
Explore the cytokines level production of IL-2 in patients with primary ITP at different disease phases and its possible role in pathogenesis of primary ITP
Measurement by ELISA
Measured: 1 May 2022 to 1 September
Explore the cytokines level production of IL-17 in patients with primary ITP at different disease phases and its possible role in pathogenesis of primary ITP
Measurement by ELISA
Measured: 1 May 2022 to 1 September
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 May 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2023 (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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- Hend M Moness, professor, Principal investigator, Faculty Of Medicine, Minya universityAliaa S Abd EL Fatah, professor, Principal investigator, Faculty Of Medicine, Minya universityRasha F Ahmed, professor, Principal investigator, Faculty of medicine, Minya university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371743
- Sponsor's protocol ID
- 290-2022
- Acronym
- microRNAITP
- Status last verified
- Apr 2023
- First submitted
- 7 May 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballantine LE, Ong J, Midgley A, Watson L, Flanagan BF, Beresford MW. The pro-inflammatory potential of T cells in juvenile-onset systemic lupus erythematosus. Pediatr Rheumatol Online J. 2014 Jan 16;12:4. doi: 10.1186/1546-0096-12-4.
PubMed 24433387Hu Y, Li H, Zhang L, Shan B, Xu X, Li H, Liu X, Xu S, Yu S, Ma D, Peng J, Hou M. Elevated profiles of Th22 cells and correlations with Th17 cells in patients with immune thrombocytopenia. Hum Immunol. 2012 Jun;73(6):629-35. doi: 10.1016/j.humimm.2012.04.015. Epub 2012 Apr 23.
PubMed 22537755
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma microRNA Levels and Some Cytokines Expression in Patients With Primary Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT05371743
- Acronym / sponsor ID
- microRNAITP / 290-2022
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- MicroRNA, ITP, IL17
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 12 May 2022 (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 disease characterized by low platelet counts with or without mucocutaneous bleeding (McMillan, 2007). Like the majority of autoimmune diseases, ITP is an organ-specific disease, and abnormalities in the regulation of the immune system have been shown to play an important role in the initiation and/or perpetuation of the disease (McKenzie et al.,2013).
Still, immune thrombocytopenia (ITP) is a significant clinical problem due to chronicity, treatment cost, occurrence mainly in, young, and relatively poorer quality of life
Detailed description
In recent years the critical role of miRNAs has been established in many diseases, including autoimmune disorders. Immune thrombocytopenic purpura (ITP) is a predominant autoimmune disease, in which aberrant expression of miRNAs has been observed, suggesting that miRNAs are involved in its development (Jafarzadeh et al., 2021). Studies have also shown that cell-free miRNAs in circulation are stable and that such miRNAs may be exploited as novel disease markers (Etheridge et al.,2011) and ( van Rooij et al., 2008).
MicroRNAs (miRNAs) are endogenous small RNAs, usually 18-25 nucleotides in length. These non-coding RNAs regulate gene expression by several mechanisms, such as repressing protein translation and altering mRNA stability (Ambros, 2008. Bartel,2004). In humans, >2,000 miRNAs have been discovered. The functional significance of the majority of the identified miRNAs has yet to be fully elucidated. Studies have shown that miRNAs play important roles in hematopoietic differentiation, e. g. megakaryocytopoiesis. (Garzon et al., 2008) and erythropoiesis ( Masaki et al., 2007 )and (Bruchovaetal., 2007), and in hematological malignancies (Rossi et al.,2010) and (Visone et al.,2009). More recently, miRNAs have also been implicated in cellular immune responses that contribute to ITP (Jernas et al., 2013) and (McKenzie etal., 2013). It was found that 23 differentially expressed miRNAs in ITP (14 up-regulated and 9 down-regulated) Altered miRNA expression may occur in specific diseases and at specific disease stages (Martin et al., 2012) Also, Recent studies have demonstrated that Th17, which is characterized for its production of IL-17, is elevated in ITP patients (Hu et al., 2012) and (Huber et al., 2007). IL-17 belongs to the IL-17 cytokine family. Increased IL-17 expression has been observed in various autoimmune diseases, such as rheumatoid arthritis (RA) ( Roeleveld et al., 2013) and systemic lupus erythematosus (SLE) (Ballantine et al., 2014). This evidence suggests that IL-17 may be associated with autoimmune diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITP patients | – | Diagnostic Test: Plasma RNA isolation, qPCR analysis of micro RNA, Diagnostic Test: estimation of serum level of IL2, Diagnostic Test: estimation of serum level of IL17Patients will be recruited from the internal department- hematology unit outpatient clinic of El Minia University Hospital in collaboration with the clinical pathology department of El Minia University Hospital and the biochemistry department of Minia and Sohag University. Exclusion criteria: 1. Secondary causes of ITP as systemic lupus erythematous (SLE), viral infections (HIV, hepatitis B or C infections) 2. Other underlying medical diseases that may cause thrombocytopenia as: * malignancy * megaloblastic anemia * aplastic anemia * lymphoproliferative disorders * liver disease * renal impairment * pregnancy 3. Organomegally and/or lymphadenopathy. 4. Recent history of vaccination. 5. Recent evidence of bacterial infection. |
| normal individuals | – | –Blood samples will be taken from normal individuals. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a cross-sectional study. Patients will be recruited from the internal department- hematology unit outpatient clinic of El Minia University Hospital in collaboration with the clinical pathology department El Minia University Hospital and the biochemistry department of Minia and Sohag University. Research Ethics Medical Review Board of El-Minia University has approved the protocol.
Key inclusion criteria (1 listed)
- ITP patients
Key exclusion criteria (8 listed)
- 1- Secondary causes of ITP as systemic lupus erythematosus (SLE), viral infections (HIV, hepatitis B or C infections) 2- Other underlying medical diseases that may cause thrombocytopenia as:
- malignancy
- megaloblastic anemia
- aplastic anemia
- lymphoproliferative disorders
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 |
|---|---|---|
| Plasma RNA isolation, qPCR analysis of micro RNAqPCR will be performed using Taqman microRNA assays (Applied Biosystems, Foster City, CA, USA) according to the manufacturer's protocol. Total RNAs going to be used to make cDNAs using TaqMan microRNA RT Kit. Diluted cDNAs were mixed with TaqMan Universal PCR Master Mix (No AmpErase UNG). Taqman miRNA assay will run in the 7500 Real-Time PCR System (Applied Biosystems). miR-39 also will be used as an exogenous control. All assays will be done in triplicates. The expression levels will be evaluated using the comparative cycle threshold (∆∆_Ct) method | Diagnostic test | ITP patients |
| estimation of serum level of IL22ml of patient serum will be used to measure IL 2 in patients with different groups by ELISA technique. The techniques will be done in the central research laboratory in Sohag university hospital | Diagnostic test | ITP patients |
| estimation of serum level of IL172ml of patient serum will be used to measure IL17 in patients with different groups by ELISA technique. The techniques will be done in the central research laboratory in Sohag university hospital | Diagnostic test | ITP patients |
Primary outcome
Evaluation of some plasma miRNA profiling in primary ITP and correlation to disease phases and their possible roles in pathogenesis of ITP
Time frame: 1 May 2022 to 1 September
Measurement of Micro RNA by qPCR
Explore the cytokines level production of IL-2 in patients with primary ITP at different disease phases and its possible role in pathogenesis of primary ITP
Time frame: 1 May 2022 to 1 September
Measurement by ELISA
Explore the cytokines level production of IL-17 in patients with primary ITP at different disease phases and its possible role in pathogenesis of primary ITP
Time frame: 1 May 2022 to 1 September
Measurement by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 24433387Ballantine LE, Ong J, Midgley A, Watson L, Flanagan BF, Beresford MW. The pro-inflammatory potential of T cells in juvenile-onset systemic lupus erythematosus. Pediatr Rheumatol Online J. 2014 Jan 16;12:4. doi: 10.1186/1546-0096-12-4.
- Background: PubMed 22537755Hu Y, Li H, Zhang L, Shan B, Xu X, Li H, Liu X, Xu S, Yu S, Ma D, Peng J, Hou M. Elevated profiles of Th22 cells and correlations with Th17 cells in patients with immune thrombocytopenia. Hum Immunol. 2012 Jun;73(6):629-35. doi: 10.1016/j.humimm.2012.04.015. Epub 2012 Apr 23.
- 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.
Hend M Moness, professor principal investigator
Faculty Of Medicine, Minya university
Aliaa S Abd EL Fatah, professor principal investigator
Faculty Of Medicine, Minya university
Rasha F Ahmed, professor principal investigator
Faculty of medicine, Minya university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary 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 1 inclusion and 8 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 12 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha S Shafik, lecturer (01067261504 ext. +20, Nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of some plasma miRNA profiling in primary ITP and correlation to disease phases and their possible roles in pathogenesis of ITP (time frame: 1 May 2022 to 1 September). 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?
On the ClinicalTrials.gov record for NCT05371743, 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 12 Apr 2023.