Clinical trial NCT05371743: Plasma microRNA Levels and Some Cytokines Expression in Patients With ITP Primary Immune Thrombocytopenic Purpura (ITP)
Official title: Plasma microRNA Levels and Some Cytokines Expression in Patients With Primary Immune Thrombocytopenic Purpura (ITP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Immune Thrombocytopenia
Keywords: MicroRNA, ITP, IL17
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* ITP patients

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of some plasma miRNA profiling in primary ITP and correlation to disease phases and their possible roles in pathogenesis of ITP
timeFrame: 1 May 2022 to 1 September
measure: 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
timeFrame: 1 May 2022 to 1 September
measure: 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
timeFrame: 1 May 2022 to 1 September
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Faculty Of Medicine, Minya university
name: Hend M Moness, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty Of Medicine, Minya university
name: Aliaa S Abd EL Fatah, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of medicine, Minya university
name: Rasha F Ahmed, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hu 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.