Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients:Correlation With Disease Activity and Chronic Organ Damage in These Patients

Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients : Correlation With Disease Activity and Chronic Organ Damage in These Patients

The study aim to evaluate the relationship between some important hematologic indices in juvenile lupus erythematosus patients and if these indices may be use as markers of disease acitivity in these patients or not ,also evaluate the relationship with these markers and chronic organ damage index

Study Overview

• Status: Recruiting
• Conditions: Juvenile Systemic Lupus Erythematosus

Detailed Description

We calculate important hematologic indices in children diagnosed as SLE as systemic inflamatory index ,systemic inflamatory response index and aggregate index of systemic inflamation in these patients ,and correlate these indices with SLE disease activity index and chronic damage index in these patients.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Alshimaa H Khalaf; Phone Number: 01067790054; Email: elshimaa011054@med.sohag.edu.eg
• Study Contact Backup: Name: Esam M Abualfadl; Phone Number: 01123977966

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Faculty of medicine
    • Contact: Alshimaa H Khalaf, Assistant lecturer; Phone Number: 01067790054; Email: elshimaa011054@med.sohag.edu.eg
    • Contact: Esam M Abualfadl, Professor; Phone Number: 01123977966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients males or females below age of 18 years diagnosed as juvenile systemic lupus erythematosus based on 2012 SLICC criteria or 2019 ACR/EULAR criteria

Description

Inclusion Criteria:

• patients who fillful 2012 SLICC criteria or 2019 ACR/EULAR criteria of systemic lupus erythematosus
• Age of patients at disease onset before 18 years

Exclusion Criteria:

• Adult onset disease ( age at disease onset after 18 years
• Any other chronic inflamatory disorders or other autoimmune diseases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of hematological indices in juvenile lupus erythematosus patients	Calculation of systemic inflamatory index,systemic information response index and aggregate index of systemic inflamation ,and correlate these indices to SLE disease activity index	3_ 6 months
Correlation between hematologic indices in juvenile lupus erythematosus patients and disease activity in these patients	SLEDAI score in juvenile lupus erythematosus patients	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculation of chronic damage index in juvenile lupus erythematosus patients	SLICC/ACR score in juvenile lupus erythematosus patients	3_6 months
Relationship between hematologic index and chronic organ damage index in juvenile lupus erythematosus patients	SLICC/ACR score	3-6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Aringer M, Petri M. New classification criteria for systemic lupus erythematosus. Curr Opin Rheumatol. 2020 Nov;32(6):590-596. doi: 10.1097/BOR.0000000000000740.
• Liu P, Li P, Peng Z, Xiang Y, Xia C, Wu J, Yang B, He Z. Predictive value of the neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-neutrophil ratio, and neutrophil-to-monocyte ratio in lupus nephritis. Lupus. 2020 Aug;29(9):1031-1039. doi: 10.1177/0961203320929753. Epub 2020 Jun 5.
• Hassan MR, Hossain A, Mahata J, Srivastava V, Sarkar S. Hematological manifestation of Pediatric Systemic Lupus Erythematosus (SLE) - A single centered cross-sectional study. J Family Med Prim Care. 2024 May;13(5):1787-1792. doi: 10.4103/jfmpc.jfmpc_1583_23. Epub 2024 May 24.

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): February 2, 2026

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Soh-Med-24-11_3MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No