Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Diagnostic Test: CBCDiagnostic Test: Antinuclear Antibody tests (ANA)Diagnostic Test: Rest of ANA profileDiagnostic Test: C3 and C4 complement level.Diagnostic Test: Anti phospholipid markerDiagnostic Test: Serum creatinine and Alb/create ratioOther: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.Other: SLEDAI scores
- Registration Number
- NCT06294483
- Lead Sponsor
- Sohag University
- Brief Summary
The present study aims to:
Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity.
- Detailed Description
This is a cross sectional study, patients with SLE will be gathered from the Internal medicine department and Rheumatology and Immunology outpatient clinic in Sohag university hospital. All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
In this study, 100 SLE patients will be classified into two groups:
Group A: early onset SLE (age at diagnosis \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50
Data collection procedure:
The following clinical data will be collected:
Clinical assessment:
Name, age, gender, smoker or ex-smoker or non-smoker, blood pressure and body mass index.
Clinical manifestations as:
Malar rash. Discoid rash. Photosensitivity. Mucocutaneous or oral ulcer. Alopecia. Raynaud's phenomena. History of deep venous thrombosis. Cutaneous vasculitis. Fever. Lupus nephritis. Arthritis. Myositis. Secondary antiphospholipid syndrome. Serositis. Pleural effusion. Renal manifestations (puffiness and lower limb edema). Neurological (headache, seizers, psychosis and Disturbed conscious level)
Hematological manifestations:
Thrombocytopenia (bleeding tendency) Anemia and Hemolytic anemia (anemic manifestation). Hypertension. Diabetes mellitus. Previous coronary event or Peripheral vascular disease.
Laboratory assessment:
1. CBC with differential WBCs count.
2. Antinuclear Antibody tests (ANA).
3. Anti-double-stranded DNA (ds DNA).
4. Anti-Sm.
5. C3 and C4 complement level.
6. Serum creatinine level.
7. Anti phospholipid marker (if needed). Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
The present study aims to:
Compare clinical features, and disease activity as SLEDAI score between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity
Duration of study:
Six months after approval of the protocol by Medical Research Ethics Committee of Sohag faculty of medicine.
Inclusion criteria:
All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Exclusion Criteria:
Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
- Patients received glucocorticoid or immunosuppressant medication. Patients presented with other chronic inflammatory diseases, infection, or other autoimmune diseases at the time of diagnosis Malignancy Pregnancy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description early onset SLE Serum creatinine and Alb/create ratio group of patients diagnosed as SLE before age of fifty years old early onset SLE 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. group of patients diagnosed as SLE before age of fifty years old early onset SLE SLEDAI scores group of patients diagnosed as SLE before age of fifty years old late onset SLE CBC Patients were diagnosed as SLE at age of fifty years old or more late onset SLE SLEDAI scores Patients were diagnosed as SLE at age of fifty years old or more early onset SLE Antinuclear Antibody tests (ANA) group of patients diagnosed as SLE before age of fifty years old early onset SLE Rest of ANA profile group of patients diagnosed as SLE before age of fifty years old late onset SLE Rest of ANA profile Patients were diagnosed as SLE at age of fifty years old or more early onset SLE CBC group of patients diagnosed as SLE before age of fifty years old early onset SLE C3 and C4 complement level. group of patients diagnosed as SLE before age of fifty years old early onset SLE Anti phospholipid marker group of patients diagnosed as SLE before age of fifty years old late onset SLE Anti phospholipid marker Patients were diagnosed as SLE at age of fifty years old or more late onset SLE Serum creatinine and Alb/create ratio Patients were diagnosed as SLE at age of fifty years old or more late onset SLE 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Patients were diagnosed as SLE at age of fifty years old or more late onset SLE Antinuclear Antibody tests (ANA) Patients were diagnosed as SLE at age of fifty years old or more late onset SLE C3 and C4 complement level. Patients were diagnosed as SLE at age of fifty years old or more
- Primary Outcome Measures
Name Time Method Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. for 2 weeks after admission of patient in sohag university hospital After detection of previous outcome \[ disease activity , clinical feature,haematological indices \] we will compare them to detect the correlation between them for every patient
Evaluate the hematological indices as (mean platelet volume) of our SLE patient. for 2 weeks after admission of patient in sohag university hospital] Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect mean platelet volume
Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient. for 2 weeks after admission of patient in sohag university hospital] Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect platelet lymphocyte ratio
Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. for 2 weeks after admission of patient in sohag university hospital] Each clinical data and laboratory results will be put into the SLEDAI score. The score is considered accurate and reliable. Categories of disease activity based on SLEDAI scores are as follows: no activity (SLEDAI= 0), mild activity (SLEDAI= 1-5), moderate activity (SLEDAI= 6-10), high activity (SLEDAI= 11-19) and very high activity (SLEDAI= 20).
Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient. for 2 weeks after admission of patient in sohag university hospital] Neutrophils, lymphocytes, and platelets play important roles in the course of various diseases . In recent years, there has been a growing interest in the role of hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) to estimate disease activity in some auto-immune diseases as and SLE . Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), as CBC parameters, have recently shown to be useful markers of inflammation in autoimmune and inflammatory disorders so we will do CBC for our pt to detect this neutrophil lymphocyte ratio
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sohag university hospital
🇪🇬Sohag, Egypt