Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
NCT ID: NCT06294483
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2024-01-10
2024-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
CROSS_SECTIONAL
Study Groups
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early onset SLE
group of patients diagnosed as SLE before age of fifty years old
CBC
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
Rest of ANA profile
As tool of diagnosis of SLE
C3 and C4 complement level.
As method of detection of acute acivity of SLE
Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
Serum creatinine and Alb/create ratio
To detct complication of disease on kidney
2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Is criteria of diagnosis of SLE
SLEDAI scores
Is score to detect the activity of disease
late onset SLE
Patients were diagnosed as SLE at age of fifty years old or more
CBC
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
Rest of ANA profile
As tool of diagnosis of SLE
C3 and C4 complement level.
As method of detection of acute acivity of SLE
Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
Serum creatinine and Alb/create ratio
To detct complication of disease on kidney
2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Is criteria of diagnosis of SLE
SLEDAI scores
Is score to detect the activity of disease
Interventions
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CBC
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
Rest of ANA profile
As tool of diagnosis of SLE
C3 and C4 complement level.
As method of detection of acute acivity of SLE
Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
Serum creatinine and Alb/create ratio
To detct complication of disease on kidney
2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Is criteria of diagnosis of SLE
SLEDAI scores
Is score to detect the activity of disease
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Esraa Ali kobsy
: internal medicine resident in Sohag university hospital
Locations
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Sohag university hospital
Sohag, , Egypt
Countries
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Other Identifiers
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Soh-Med-24-01-09MS
Identifier Type: -
Identifier Source: org_study_id
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