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Status unknownNCT05724940Updated Feb 22, 2023

Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus

An observational study in Systemic Lupus Erythematosus (SLE), sponsored by Sohag University. Status unknown. Open to participants aged 6 Months to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
150
Ages
6 Months to 80 Years
Sex
All
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Study 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.

Read the detailed 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.
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Conditions studied

  • Systemic Lupus Erythematosus (SLE)
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 150 is close to the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

  1. Age juvenile SLE 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, late onset SLE was defined as a diagnosis at more than 50 years of age).

Eligibility criteria

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • Otherclinical 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: 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( Systemic Lupus International Collaborating Clinics) 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 (Antinuclear Antibodies)test. 6. ANA profile for the most common 19 autoantibodies by immunoblot.

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What researchers measure

Primary outcomes

  1. serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.

    1. SLE disease activity index SLEDAI (ref) to assessment disease activity in patient . 2. ANA test (antinuclear antibodies ) to assessment auto-antibodies in different age grouped

    Time frame: 1-1-2024

  2. laboratory differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.

    1. Renal biopsy for assessment kidney damage 2. urine analysis to detect albumin in urine 3. liver function to detect liver affection

    Time frame: 1-1-2024

  3. hematological affection among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.

    1. cbc complete blood picture to assessment bone marrow affection 2. erythrocyte sedimentation rate to detect disease activity.

    Time frame: 1-1-2024

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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; 50: 85-95. 3 Fessler BJ, Boumpas DT. Severe major organ involvement in systemic lupus erythematosus. Diagnosis and management. Rheum Dis Clin North Am 1995; 21: 81-98. 4 Borchers AT, Naguwa SM, Shoenfeld Y, Gershwin ME. The geoepidemiology of systemic lupus erythematosus. Autoimmun Rev 2010; 9: A277-A287. 5 Ferna´ ndez M, Alarco´ n GS, Calvo-Ale´n J, et al. A multiethnic, multicenter cohort of patients with systemic lupus erythematosus (SLE) as a model for the study of ethnic disparities in SLE. Arthritis Rheum 2007; 57: 576-584. 6 Arbuckle MR, James JA, Dennis GJ, et al. Rapid clinical progression to diagnosis among African-American men with systemic lupus erythematosus. Lupus 2003; 12: 99-106.

Study documents

  • Study protocol · Dec 22, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05724940
Lead sponsor
Sohag University
Responsible party
Alaa Mohamed Hemdan (assistant lecture, Sohag University) — Principal investigator
First posted
Feb 13, 2023
Start date
Mar 15, 2023 (estimated)
Primary completion
Jan 1, 2024 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Feb 22, 2023

Study contacts

alaa mo hemdan, assistant
Contact
alaahemdan25@yahoo.com
01067302847
hanan sa abozaid, Professor
Contact
hanan27eg@yahoo.com
01017049050
essam mo aboelfadl, professor
study director · sohag

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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