NCT06227559

Brief Summary

Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement, leading to inflammatory damage to the joints, kidney, central nervous system, and hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus in a developing country is not known, as per literature the female-to-male ratio rises from 4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients. \- The full mechanism of SLE is still unknown however, production of autoantibodies and immune complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in multiple immune regulatory networks, are central to organ inflammation and subsequent damage in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and relapses.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 17, 2023

Last Update Submit

January 25, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Measure the absolute neutrophil-to-absolute lymphocyte ratio (NLR).

    Measuring the absolute neutrophil-to-absolute lymphocyte ratio (NLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

    Baseline

  • Measure the mean platelet volume (MPV).

    Measuring the mean platelet volume (MPV) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

    Baseline

  • Measure the platelet count-to-absolute lymphocytes ratio (PLR).

    Measuring the platelet count-to-absolute lymphocytes ratio (PLR) by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

    Baseline

  • Measuring the monocyte distribution width (MDW)}.

    Measuring the monocyte distribution width (MDW)} by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )

    Baseline

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

this study will include all patients diagnosed and followed up as jSLE, and will be consecutively recruited from the inpatient and outpatient clinic of Immunology and rheumatology department at Assuit University children's hospital

You may qualify if:

  • Age at enrollment ≤18 years old.
  • Both sexes
  • The Patients should be diagnosed as jSLE, according to 2019 European league against rheumatism (EULAR)/ American college of rheumatology (ACR) SLE classification criteria, or the previous ACR 1997 SLE classification criteria.

You may not qualify if:

  • Patients with autoimmune diseases other than j SLE
  • Patients not fulfilling the criteria for diagnosis of SLE
  • Active infections.
  • Malignancies.
  • Lymphoproliferative disorders.
  • Hematologic diseases
  • Hepatosplenic diseases and diabetic nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 17, 2023

First Posted

January 29, 2024

Study Start

February 1, 2024

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

January 29, 2024

Record last verified: 2024-01