Clinical trial NCT06610409: Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity
Official title: Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SLE (Systemic Lupus)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 SLE patients and 40 healthy controls

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* Patients who are diagnosed as SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) Citeria (10,11).

Exclusion Criteria:

* age \< 18 years old

  * Patients unwilling to participate in the study.
  * Patients with other autoimmune diseases.
  * Patients with malignancy or infections.
  * Pregnancy and lactation

Primary outcomes:
measure: To assess CXCL5 level in SLE patients compared to healthy controls
timeFrame: 2024 -2027
measure: To assess CXCL5 level in association with disease activity
timeFrame: 2024-2027
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty of medicine Assiut University
state: Dairuit
Study officials:
References:
citation: 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.
citation: Zhang 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.