Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity

September 20, 2024 updated by: Reem Amr Mohamed Essmat, Assiut University
Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dairuit
      • Assuit, Dairuit, Egypt
        • Faculty of Medicine Assiut University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

50 SLE patients and 40 healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Diagnostic test: blood sampling
Blood sample for CXCL5 Level
SLE patients
Diagnostic test: blood sampling
Blood sample for CXCL5 Level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess CXCL5 level in SLE patients compared to healthy controls
Time Frame: 2024 -2027
2024 -2027
To assess CXCL5 level in association with disease activity
Time Frame: 2024-2027
2024-2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CXCL5 in SLE patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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