Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.

NCT06294483 | Enrolling By Invitation

• 1 other identifier: Soh-Med-24-01-09MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (5)

• Evaluate the hematological indices as (mean platelet volume) of our SLE patient.

  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

  for 2 weeks after admission of patient in sohag university hospital]

• Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.

  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

  for 2 weeks after admission of patient in sohag university hospital]

• Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.

  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

  for 2 weeks after admission of patient in sohag university hospital]

• Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.

  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).

  for 2 weeks after admission of patient in sohag university hospital]

• 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.

  After detection of previous outcome \[ disease activity , clinical feature,haematological indices \] we will compare them to detect the correlation between them for every patient

  for 2 weeks after admission of patient in sohag university hospital

Study Arms (2)

early onset SLE

group of patients diagnosed as SLE before age of fifty years old

Diagnostic Test: CBC; Diagnostic Test: Antinuclear Antibody tests (ANA); Diagnostic Test: Rest of ANA profile; Diagnostic Test: C3 and C4 complement level.; Diagnostic Test: Anti phospholipid marker; Diagnostic Test: Serum creatinine and Alb/create ratio; Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.; Other: SLEDAI scores

late onset SLE

Patients were diagnosed as SLE at age of fifty years old or more

Diagnostic Test: CBC; Diagnostic Test: Antinuclear Antibody tests (ANA); Diagnostic Test: Rest of ANA profile; Diagnostic Test: C3 and C4 complement level.; Diagnostic Test: Anti phospholipid marker; Diagnostic Test: Serum creatinine and Alb/create ratio; Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.; Other: SLEDAI scores

Interventions

CBC DIAGNOSTIC_TEST

Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity

early onset SLE; late onset SLE

Antinuclear Antibody tests (ANA) DIAGNOSTIC_TEST

To be tool in diagnosis of SLE

early onset SLE; late onset SLE

Rest of ANA profile DIAGNOSTIC_TEST

As tool of diagnosis of SLE

early onset SLE; late onset SLE

C3 and C4 complement level. DIAGNOSTIC_TEST

As method of detection of acute acivity of SLE

early onset SLE; late onset SLE

Anti phospholipid marker DIAGNOSTIC_TEST

To detect antiphospholipid syndrome if there is sign of thrombosis

early onset SLE; late onset SLE

Serum creatinine and Alb/create ratio DIAGNOSTIC_TEST

To detct complication of disease on kidney

early onset SLE; late onset SLE

2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. OTHER

Is criteria of diagnosis of SLE

early onset SLE; late onset SLE

SLEDAI scores OTHER

Is score to detect the activity of disease

early onset SLE; late onset SLE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 \< 50 years). Group B: late onset SLE. (age at diagnosis ≥ 50 years).

You may qualify if:

• All patients fulfilled 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : internal medicine resident in Sohag university hospital

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: March 5, 2024
• Study Start: January 10, 2024
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

EG (1)