Clinical trial NCT06294483: Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
Official title: Comparison of Clinical Features, Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.

While include In this study as 100 SLE patients will be classified into two groups:

Group A: early onset SLE (age at diagnosis \&amp;lt; 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50 years).

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 \&lt; 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the hematological indices as (mean platelet volume) of our SLE patient.
timeFrame: for 2 weeks after admission of patient in sohag university hospital]
measure: Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.
timeFrame: for 2 weeks after admission of patient in sohag university hospital]
measure: Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.
timeFrame: for 2 weeks after admission of patient in sohag university hospital]
measure: Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
timeFrame: for 2 weeks after admission of patient in sohag university hospital]
measure: 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.
timeFrame: for 2 weeks after admission of patient in sohag university hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References: