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

NCT06718283 | Recruiting DMC

• 1 other identifier: Soh-Med-24-11_3MD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Juvenile Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Calculation of chronic damage index in juvenile lupus erythematosus patients

  3_6 months

• Relationship between hematologic index and chronic organ damage index in juvenile lupus erythematosus patients

  3-6 months

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of medicine

Sohag, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 32925250 BACKGROUND

• 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.

  PMID: 32501169 BACKGROUND

• 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.

  PMID: 38948621 BACKGROUND

Central Study Contacts

Alshimaa H Khalaf

CONTACT

01067790054; elshimaa011054@med.sohag.edu.eg

Esam M Abualfadl

CONTACT

01123977966

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer- Rheumatology and Rehabilitation department

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 5, 2024
• Study Start: November 30, 2024
• Primary Completion: October 15, 2025
• Study Completion: February 2, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

EG (1)