Systemic Lupus Erythematosus (SLE)NCT05724940
Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus (SLE), run by Sohag University.
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. Read more about this study
- Who is it for?
- Ages 6 months to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 80 years
- All sexes
- Child, Adult, Older adult
Study population: 2. 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).
Who may be able to join
- Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology )
- 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).
- Patients with a disease duration of more than 6 months
Who cannot join
- 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 .
- Patients who are not willing to be involved in the study
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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:
- 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 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 test.
- ANA profile for the most common 19 autoantibodies by immunoblot.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patientsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-1-2024
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
Measured: 1-1-2024
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.
Measured: 1-1-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Mar 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Hemdan, Sohag University
- Investigators
- essam mo aboelfadl, professor, Study director, sohag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724940
- Sponsor's protocol ID
- soh-med-22-12-15
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Serological Differences Among Juvenile, Adult, and Late-onset Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05724940
- Acronym / sponsor ID
- soh-med-22-12-15
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methods:
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 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 test.
- ANA profile for the most common 19 autoantibodies by immunoblot.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 2. 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).
Key inclusion criteria (3 listed)
- Patients diagnosed as SLE( Systemic lupus erythematosus )according to EULAR / ACE (European League Against Rheumatism /American College of Rheumatology )
- 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).
- Patients with a disease duration of more than 6 months
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical and serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patientsAll 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. | Other | – |
Primary outcome
serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time frame: 1-1-2024
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
laboratory differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time frame: 1-1-2024
1. Renal biopsy for assessment kidney damage 2. urine analysis to detect albumin in urine 3. liver function to detect liver affection
hematological affection among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital.
Time frame: 1-1-2024
1. cbc complete blood picture to assessment bone marrow affection 2. erythrocyte sedimentation rate to detect disease activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Results publication1 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
essam mo aboelfadl, professor study director
sohag
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact alaa mo hemdan, assistant (01067302847, alaahemdan25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serological differences among juvenile, adult, and late-onset systemic lupus erythematosus in a cohort of SLE patients in our hospital. (time frame: 1-1-2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.