Plasma microRNA Levels and Some Cytokines Expression in Patients With ITP Primary Immune Thrombocytopenic Purpura (ITP)

NCT05371743 | Unknown DMC

• 1 other identifier: 290-2022
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Immune Thrombocytopenia

Keywords

MicroRNA, ITP, IL17

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  1 May 2022 to 1 September

Study Arms (2)

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.

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.

Interventions

Plasma RNA isolation, qPCR analysis of micro RNA DIAGNOSTIC_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

ITP patients

estimation of serum level of IL2 DIAGNOSTIC_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

ITP patients

estimation of serum level of IL17 DIAGNOSTIC_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

ITP patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ITP patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, 82733, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 24433387 BACKGROUND

• 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.

  PMID: 22537755 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

After informed patient consent, Blood samples will be taken when patients visited the hospital and an ITP diagnosis was made. For persistent, chronic, and acute ITP patients.

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Hend M Moness, professor

  Faculty Of Medicine, Minya university

  PRINCIPAL INVESTIGATOR

• Aliaa S Abd EL Fatah, professor

  Faculty Of Medicine, Minya university

  PRINCIPAL INVESTIGATOR

• Rasha F Ahmed, professor

  Faculty of medicine, Minya university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha S Shafik, lecturer

CONTACT

01067261504; Nohasaber@med.sohag.edu.eg

Doaa M Elroby, lecturer

CONTACT

01009374489; dosa.elroby@pharm.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Medical Microbiology and Immunology, faculty of medicine

Study Record Dates

• First Submitted: May 7, 2022
• First Posted: May 12, 2022
• Study Start: May 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)