Systemic Lupus ErythematosusNCT05105217
Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients
An observational study of Systemic Lupus Erythematosus, run by Assiut University.
Trial summary
1.Assessment of slit2 level in SLE patients and its correlation with disease activity. 2-Assessment of slit2 level in SSC patients and its correlation with disease activity Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Slit2 biomarker
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Feb 2023
- 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 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: 1. Adult SLE Patients 2. Adult SSC patients 3. Adult healthy control
Who may be able to join
- Adult SLE Patients who fulfilled the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus .
- Adult SSC patients who fulfilled the 2013 EULAR / ACR for SSC
Who cannot join
- Individuals with other autoimmune diseases
Trial locations and contacts
No sites are listed yet.
About this study
1.Assessment of slit2 level in SLE patients and its correlation with disease activity.
2-Assessment of slit2 level in SSC patients and its correlation with disease activity
Read the detailed description
Systemic lupus erythematosus (SLE) is the most serologically and clinically diverse autoimmune disease. Immune dysregulation leads to excess production of autoantibodies and immune complexes. excess complement activation, and insidious tissue inflammation in patients with SLE.
SLE is characterized by multisystem involvement commonly affecting the skin, renal, and musculoskeletal systems .
Lupus nephritis is an important cause of both acute kidney injury and chronic kidney disease that can result in end-stage renal disease. Its pathogenic mechanisms are characterized by aberrant activation of both innate and adaptive immune responses, dysregulation of inflammatory signaling pathways, and increased cytokines production .
Systemic sclerosis (SSC) is an autoimmune disease with characteristic vascular damage and fibrosis of the skin and internal organs. Diagnosis of SSC is mainly based on the clinical course and features in addition to laboratory findings including autoantibody profiles
. Slit2, as a member of the Slit family, is secreted glycoprotein. Slit2 functions by binding to its transmembrane receptor Robo. Robo has four isoforms (Robo14). Slit2-Robo regulates cell functions, such as regulating leukocytes in chemotaxis and promoting endothelial cell migration and tube formation.
Slit2 might promote the pathogenesis of LN by affecting various cell dysfunction in addition to leukocyte infiltration.
In SSC, vascular involvement is a primary event characterized by vascular tone dysfunction and microcirculatory abnormalities. Many classes of guidance molecules, such as members of the secreted glycoproteins Slits and their Roundabout (Robo) receptors, play critical roles in angiogenesis. Among these, Robo1 and Robo4 are expressed in endothelial cells. .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Slit2 biomarker
- Keywords
- systemic sclerosis
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slit2 biomarkerOther
1.Assessment of slit2 level in SLE patients and its correlation with disease activity.
2-Assessment of slit2 level in SSC patients and its correlation with disease activity
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the level of slit2 by ELISA in SLE patients
determining level of Slit2 in patients with SLE and define its correlation with disease activity
Measured: baseline
Secondary outcomes (1)
measure the level of slit2 by ELISA in SSC patients
determining level of Slit2 in patients with SSC and define its correlation with disease activity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Safwat Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105217
- Sponsor's protocol ID
- Slit2 in SLE & SSC
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05105217
- Acronym / sponsor ID
- Slit2 in SLE & SSC
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- systemic sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 3 Nov 2021 (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.
1.Assessment of slit2 level in SLE patients and its correlation with disease activity.
2-Assessment of slit2 level in SSC patients and its correlation with disease activity
Detailed description
Systemic lupus erythematosus (SLE) is the most serologically and clinically diverse autoimmune disease. Immune dysregulation leads to excess production of autoantibodies and immune complexes. excess complement activation, and insidious tissue inflammation in patients with SLE.
SLE is characterized by multisystem involvement commonly affecting the skin, renal, and musculoskeletal systems .
Lupus nephritis is an important cause of both acute kidney injury and chronic kidney disease that can result in end-stage renal disease. Its pathogenic mechanisms are characterized by aberrant activation of both innate and adaptive immune responses, dysregulation of inflammatory signaling pathways, and increased cytokines production .
Systemic sclerosis (SSC) is an autoimmune disease with characteristic vascular damage and fibrosis of the skin and internal organs. Diagnosis of SSC is mainly based on the clinical course and features in addition to laboratory findings including autoantibody profiles
. Slit2, as a member of the Slit family, is secreted glycoprotein. Slit2 functions by binding to its transmembrane receptor Robo. Robo has four isoforms (Robo14). Slit2-Robo regulates cell functions, such as regulating leukocytes in chemotaxis and promoting endothelial cell migration and tube formation.
Slit2 might promote the pathogenesis of LN by affecting various cell dysfunction in addition to leukocyte infiltration.
In SSC, vascular involvement is a primary event characterized by vascular tone dysfunction and microcirculatory abnormalities. Many classes of guidance molecules, such as members of the secreted glycoproteins Slits and their Roundabout (Robo) receptors, play critical roles in angiogenesis. Among these, Robo1 and Robo4 are expressed in endothelial cells. .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Adult SLE Patients 2. Adult SSC patients 3. Adult healthy control
Key inclusion criteria (2 listed)
- Adult SLE Patients who fulfilled the 2019 EULAR/ACR Classification criteria for Systemic Lupus Erythematosus .
- Adult SSC patients who fulfilled the 2013 EULAR / ACR for SSC
Key exclusion criteria (1 listed)
- Individuals with other autoimmune diseases
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 |
|---|---|---|
| Slit2 biomarker1.Assessment of slit2 level in SLE patients and its correlation with disease activity. 2-Assessment of slit2 level in SSC patients and its correlation with disease activity | Other | – |
Primary outcome
measure the level of slit2 by ELISA in SLE patients
Time frame: baseline
determining level of Slit2 in patients with SLE and define its correlation with disease activity
1 secondary outcome
measure the level of slit2 by ELISA in SSC patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Slit2 is a potential biomarker for renal impairment in systemic lupus erythematosusLink provided by the sponsor.
- A review of advances in the understanding of lupus nephritis pathogenesis as a basis for emerging therapies \[version 1; peer review: 2 approved\]Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Assiut 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 2 inclusion and 1 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 3 Nov 2021. 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 Eman Safwat (01014116158, safwateman605@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the level of slit2 by ELISA in SLE patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.