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

March 4, 2024 updated by: Esraa Ali kobsy, Sohag University

Comparison of Clinical Features, Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
early onset SLE
group of patients diagnosed as SLE before age of fifty years old
Diagnostic test: CBC
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Diagnostic test: Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
Diagnostic test: Rest of ANA profile
As tool of diagnosis of SLE
Diagnostic test: C3 and C4 complement level.
As method of detection of acute acivity of SLE
Diagnostic test: Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
Diagnostic test: Serum creatinine and Alb/create ratio
To detct complication of disease on kidney
Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Is criteria of diagnosis of SLE
Other: 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
Diagnostic test: CBC
Is used to detect haematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and its relation to disease activity
Diagnostic test: Antinuclear Antibody tests (ANA)
To be tool in diagnosis of SLE
Diagnostic test: Rest of ANA profile
As tool of diagnosis of SLE
Diagnostic test: C3 and C4 complement level.
As method of detection of acute acivity of SLE
Diagnostic test: Anti phospholipid marker
To detect antiphospholipid syndrome if there is sign of thrombosis
Diagnostic test: Serum creatinine and Alb/create ratio
To detct complication of disease on kidney
Other: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus.
Is criteria of diagnosis of SLE
Other: SLEDAI scores
Is score to detect the activity of disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the hematological indices as (mean platelet volume) of our SLE patient.
Time Frame: 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
for 2 weeks after admission of patient in sohag university hospital]
Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient.
Time Frame: 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
for 2 weeks after admission of patient in sohag university hospital]
Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient.
Time Frame: 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
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.
Time Frame: 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).
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.
Time Frame: 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
for 2 weeks after admission of patient in sohag university hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-01-09MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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