NCT06610409

Brief Summary

Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Oct 2024Sep 2027

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 20, 2024

Last Update Submit

September 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • To assess CXCL5 level in SLE patients compared to healthy controls

    2024 -2027

  • To assess CXCL5 level in association with disease activity

    2024-2027

Study Arms (2)

SLE patients

Diagnostic Test: blood sampling

Healthy controls

Diagnostic Test: blood sampling

Interventions

blood samplingDIAGNOSTIC_TEST

Blood sample for CXCL5 Level

Healthy controlsSLE patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 SLE patients and 40 healthy controls

You may qualify if:

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

You may not qualify if:

  • age \< 18 years old
  • Patients unwilling to participate in the study.
  • Patients with other autoimmune diseases.
  • Patients with malignancy or infections.
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Assiut University

Asyut, Dairuit, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 36240108BACKGROUND
  • 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.

    PMID: 38439196BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dairuit , Assuit

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations