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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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

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

Other trials in Egypt

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).

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.

Study groups in NCT06610409
Study groupRoleWhat they receive
SLE patientsNot described
Receives: Diagnostic Test: blood sampling
Healthy controlsNot described
Receives: Diagnostic Test: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess CXCL5 level in SLE patients compared to healthy controls

    Measured: 2024 -2027

  2. 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.

  1. First posted24 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

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)
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 36240108
  • 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.

    PubMed 38439196

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