Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294483
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-05
First Post:
2024-02-04
Brief Title:
Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Comparison of Clinical Features Hematological Indices and Disease Activity Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 RheumatismAmerican 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 Raynauds 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 RheumatismAmerican 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
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 Raynauds 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 RheumatismAmerican 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None