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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05724940
Other study ID # soh-med-22-12-15
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 15, 2023
Est. completion date April 1, 2024

Study information

Verified date February 2023
Source Sohag University
Contact alaa mo hemdan, assistant
Phone 01067302847
Email alaahemdan25@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with a highly variable presentation and course. It can affect virtually every organ of the body and many symptoms may be observed. Skin, musculoskeletal, hematologic, and serological involvement are most commonly observed. Some patients show predominately hematologic, renal, or central nervous system manifestations. Studies have reported that juvenile-onset SLE patients tend to have a more aggressive presentation and course, with higher rates of organ involvement and lower life expectancy than adult-onset SLE patients. Late-onset SLE patients tend to have a more insidious onset of disease and tend to have less major organ involvement and more benign disease course. However, they have a poorer prognosis than patients who developed SLE before the age of 50 years, because of the generally higher frequency of comorbid diseases and higher organ damage, due to aging and longer exposure to ''classical'' vascular risk factors. Aims of the Study: To compare clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.


Description:

Methods: All patients will be subjected to the following: 1. Thorough medical history of the patients 2. Full clinical examination including: 1. General examination and vital signs. 2. Complete rheumatological examination. 3. SLE disease activity index SLEDAI (ref). 4. SLICC damage index (ref). 3. Routine investigations (complete blood picture, erythrocyte sedimentation rate and liver functions). 4. Renal investigations: 1. Kidney functions 2. Urine analysis 3. 24 hours protein in urine and/or A/C ratio 4. Renal biopsy if indicated. 5. ANA test. 6. ANA profile for the most common 19 autoantibodies by immunoblot.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date April 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers
Gender All
Age group 6 Months to 80 Years
Eligibility Inclusion Criteria: Inclusion criteria: 1. Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology ) 2. Age juvenile SLE ( Systemic lupus erythematosus )was defined as a diagnosis below the age of 18 years, and those diagnosed between 19 and 50 years of age were classified as adult SLE ( Systemic lupus erythematosus ), late onset SLE was defined as a diagnosis at more than 50 years of age). 3. Patients with a disease duration of more than 6 months Exclusion Criteria: - Exclusion criteria: 1. Patients with had other autoimmune diseases, such as rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease , overlap syndrome or primary Sjogren's syndrome ,but not secondary Sjogren's syndrome or secondary antiphospholipid syndrome . 2. Patients who are not willing to be involved in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients
All patients will be subjected to the following: Thorough medical history of the patients Full clinical examination including: General examination and vital signs. Complete rheumatological examination. SLE disease activity index SLEDAI (ref). SLICC( Systemic Lupus International Collaborating Clinics) damage index (ref). Routine investigations (complete blood picture, erythrocyte sedimentation rate and liver functions). Renal investigations: Kidney functions Urine analysis 24 hours protein in urine and/or A/C ratio Renal biopsy if indicated. ANA (Antinuclear Antibodies)test. ANA profile for the most common 19 autoantibodies by immunoblot.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (1)

1 Von Feldt JM. Systemic lupus erythematosus. Recognizing its various presentations. Postgrad Med 1995; 97: 79, 83, 86 passim. 2 Estes D, Christian CL. The natural history of systemic lupus erythematosus by prospective analysis. Medicine (Baltimore) 1971;

Outcome

Type Measure Description Time frame Safety issue
Primary serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital. SLE disease activity index SLEDAI (ref) to assessment disease activity in patient .
ANA test (antinuclear antibodies ) to assessment auto-antibodies in different age grouped
1-1-2024
Primary laboratory differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital. Renal biopsy for assessment kidney damage
urine analysis to detect albumin in urine
liver function to detect liver affection
1-1-2024
Primary hematological affection among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital. cbc complete blood picture to assessment bone marrow affection
erythrocyte sedimentation rate to detect disease activity.
1-1-2024
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