The Role of Some Hematological Parameters in Juvenile Systemic Lupue Erythematosus
1 other identifier
observational
60
0 countries
N/A
Brief Summary
Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients. \- The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2024
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJanuary 29, 2024
January 1, 2024
2 months
December 17, 2023
January 25, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Measure the absolute neutrophil-to-absolute lymphocyte ratio (NLR).
Measuring the absolute neutrophil-to-absolute lymphocyte ratio (NLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )
Baseline
Measure the mean platelet volume (MPV).
Measuring the mean platelet volume (MPV) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )
Baseline
Measure the platelet count-to-absolute lymphocytes ratio (PLR).
Measuring the platelet count-to-absolute lymphocytes ratio (PLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )
Baseline
Measuring the monocyte distribution width (MDW)}.
Measuring the monocyte distribution width (MDW)} by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )
Baseline
Eligibility Criteria
this study will include all patients diagnosed and followed up as jSLE, and will be consecutively recruited from the inpatient and outpatient clinic of Immunology and rheumatology department at Assuit University children's hospital
You may qualify if:
- Age at enrollment ≤18 years old.
- Both sexes
- The Patients should be diagnosed as jSLE, according to 2019 European league against rheumatism (EULAR)/ American college of rheumatology (ACR) SLE classification criteria, or the previous ACR 1997 SLE classification criteria.
You may not qualify if:
- Patients with autoimmune diseases other than j SLE
- Patients not fulfilling the criteria for diagnosis of SLE
- Active infections.
- Malignancies.
- Lymphoproliferative disorders.
- Hematologic diseases
- Hepatosplenic diseases and diabetic nephropathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 17, 2023
First Posted
January 29, 2024
Study Start
February 1, 2024
Primary Completion
April 1, 2024
Study Completion
June 1, 2024
Last Updated
January 29, 2024
Record last verified: 2024-01