SLE (Systemic Lupus)NCT06610409
Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity
An observational study of SLE (Systemic Lupus), run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SLE (Systemic Lupus)
- What is being tested?
- blood sampling
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 SLE patients and 40 healthy controls
Who may be able to join
- Age >18 years old
- Patients who are diagnosed as SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) Citeria (10,11).
Who cannot join
- age < 18 years old
- Patients unwilling to participate in the study.
- Patients with other autoimmune diseases.
- Patients with malignancy or infections.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine Assiut University
Asyut, Dairuit
Reem Amr Mohamed Esmat, Resident doctor, +201002857726, Reemamr308@gmail.com
About this study
Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity
Read the detailed description
Systemic lupus erythematosus (SLE) is a common autoimmune disease involving multiple organs and systems. SLE is characterized by the production of a large number of autoantibodies and the deposition of various immune complexes in target tissue .(1,2).
Chemokines are a large family of small secreted proteins that are identified as attractants of different types of leukocytes, including neutrophils, to sites of infection and inflammation. They are produced locally in tissues and act through interaction with specific G protein-coupled receptors that are predominantly expressed on leukocytes(3,4,5). Interaction between chemokines and their receptor plays an essential role in the development and homeostasis of the immune system as well as inflammatory response (6) . Although most chemokines promote locomotion of immune cells, some of them might inhibit leukocyte migration under certain circumstances (7).
We found in a study that serum CXCL5 levels were significantly lower in SLE patients than in healthy individuals and were negatively correlated with disease activity. By administering CXCL5 intravenously in a mouse model of lupus, mouse survival improved, and indices of disease activity reduced significantly(8,9). This finding suggests that homeostatic chemokines in peripheral blood might play an anti- inflammatory role and that serum levels of anti- inflammatory chemokines such as CXCL5 would be decreased in patients with autoimmune diseases (7) .
So in this study, we aim to determine level of CXCL5 in SLE patients , association of chemokine levels with demographics, clinical, and laboratory investigations of patients and its correlation with disease activity (7).
- Conditions
- SLE (Systemic Lupus)
- Being tested
- blood sampling
- 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.
blood samplingDiagnostic test
Blood sample for CXCL5 Level
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | Not described Receives: Diagnostic Test: blood sampling | |
| Healthy controls | Not described Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess CXCL5 level in SLE patients compared to healthy controls
Measured: 2024 -2027
To assess CXCL5 level in association with disease activity
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SLE (Systemic Lupus)Studies 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Amr Mohamed Essmat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610409
- Sponsor's protocol ID
- CXCL5 in SLE patients
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fan X, Ng CT, Guo D, Lim F, Tan JC, Law A, Goh LH, Poon ZY, Cheung A, Kong SL, Tan M, Li S, Loh A, James A, Lim T, Chen J, Thumboo J, Hwang W, Low A. Dampened Inflammation and Improved Survival After CXCL5 Administration in Murine Lupus via Myeloid and Neutrophil Pathways. Arthritis Rheumatol. 2023 Apr;75(4):553-566. doi: 10.1002/art.42383. Epub 2023 Feb 22.
PubMed 36240108Zhang L, Zhao L, Du K, Chen J, Ding H, Petersen F, Ye S, Lin Z, Yu X. Serum levels of CXCL5 are decreased and correlate with circulating platelet counts in systemic lupus erythematosus. Int J Rheum Dis. 2024 Mar;27(3):e15089. doi: 10.1111/1756-185X.15089.
PubMed 38439196
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity
- ClinicalTrials.gov ID
- NCT06610409
- Acronym / sponsor ID
- CXCL5 in SLE patients
- Conditions
- SLE (Systemic Lupus)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 24 Sep 2024 (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.
Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity
Detailed description
Systemic lupus erythematosus (SLE) is a common autoimmune disease involving multiple organs and systems. SLE is characterized by the production of a large number of autoantibodies and the deposition of various immune complexes in target tissue .(1,2).
Chemokines are a large family of small secreted proteins that are identified as attractants of different types of leukocytes, including neutrophils, to sites of infection and inflammation. They are produced locally in tissues and act through interaction with specific G protein-coupled receptors that are predominantly expressed on leukocytes(3,4,5). Interaction between chemokines and their receptor plays an essential role in the development and homeostasis of the immune system as well as inflammatory response (6) . Although most chemokines promote locomotion of immune cells, some of them might inhibit leukocyte migration under certain circumstances (7).
We found in a study that serum CXCL5 levels were significantly lower in SLE patients than in healthy individuals and were negatively correlated with disease activity. By administering CXCL5 intravenously in a mouse model of lupus, mouse survival improved, and indices of disease activity reduced significantly(8,9). This finding suggests that homeostatic chemokines in peripheral blood might play an anti- inflammatory role and that serum levels of anti- inflammatory chemokines such as CXCL5 would be decreased in patients with autoimmune diseases (7) .
So in this study, we aim to determine level of CXCL5 in SLE patients , association of chemokine levels with demographics, clinical, and laboratory investigations of patients and its correlation with disease activity (7).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | Diagnostic Test: blood sampling |
| Healthy controls | – | Diagnostic Test: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 SLE patients and 40 healthy controls
Key inclusion criteria (2 listed)
- Age >18 years old
- Patients who are diagnosed as SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) Citeria (10,11).
Key exclusion criteria (5 listed)
- age < 18 years old
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 |
|---|---|---|
| blood samplingBlood sample for CXCL5 Level | Diagnostic test | Healthy controls, SLE patients |
Primary outcome
To assess CXCL5 level in SLE patients compared to healthy controls
Time frame: 2024 -2027
To assess CXCL5 level in association with disease activity
Time frame: 2024-2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Background: PubMed 36240108Fan X, Ng CT, Guo D, Lim F, Tan JC, Law A, Goh LH, Poon ZY, Cheung A, Kong SL, Tan M, Li S, Loh A, James A, Lim T, Chen J, Thumboo J, Hwang W, Low A. Dampened Inflammation and Improved Survival After CXCL5 Administration in Murine Lupus via Myeloid and Neutrophil Pathways. Arthritis Rheumatol. 2023 Apr;75(4):553-566. doi: 10.1002/art.42383. Epub 2023 Feb 22.
- Background: PubMed 38439196Zhang L, Zhao L, Du K, Chen J, Ding H, Petersen F, Ye S, Lin Z, Yu X. Serum levels of CXCL5 are decreased and correlate with circulating platelet counts in systemic lupus erythematosus. Int J Rheum Dis. 2024 Mar;27(3):e15089. doi: 10.1111/1756-185X.15089.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE (Systemic Lupus), run by Assiut University at 1 site in Egypt.
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 5 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: opening soon, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess CXCL5 level in SLE patients compared to healthy controls (time frame: 2024 -2027). The study lists 2 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 NCT06610409, which also lists 2 linked publications.
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 24 Sep 2024.