Clinical trial NCT06718283: Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients:Correlation With Disease Activity and Chronic Organ Damage in These Patients
Official title: Assessment of Hematologic Indices in Juvenile Lupus Erythematosus Patients : Correlation With Disease Activity and Chronic Organ Damage in These Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Juvenile Systemic Lupus Erythematosus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Calculation of hematological indices in juvenile lupus erythematosus patients
timeFrame: 3_ 6 months
measure: Correlation between hematologic indices in juvenile lupus erythematosus patients and disease activity in these patients
timeFrame: 3-6 months
Secondary outcomes:
measure: Calculation of chronic damage index in juvenile lupus erythematosus patients
timeFrame: 3_6 months
measure: Relationship between hematologic index and chronic organ damage index in juvenile lupus erythematosus patients
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.