The Role of Some Hematological Parameters in Juvenile Systemic Lupue Erythematosus

January 25, 2024 updated by: Hadeer Ali Mohamed Soliman Abdullah, Assiut University

The Role of Some Hematological Parameters in Juvenile Systemic Lupus Erythematosus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

The patients with SLE may present with various systemic manifestations. The general symptoms include: fever, malaise, arthralgias, myalgias, headache, and loss of appetite and weight. Nonspecific fatigue, fever, arthralgia, and weight changes.

- JSLE prognosis is related to the affected organs/systems and is worse for children and adolescents compared to adults, perhaps due to the higher rate of renal and neurological involvement attributed to JSLE.

Over the last decades, the improvement of patient survival was mainly due to an early diagnosis and better therapeutic approach, especially regarding the severe manifestations of the disease. These included the introduction of hemodialysis, renal transplantation and use of immunosuppressive drugs and their complications, i.e., use of potent antibiotic and hypertensive drugs .

  • it is noteworthy that the hematological involvment predominates during the first years of the disease and tends to last over time, with the premise that it may be the initial manifestation of the disease. Clear examples of this are the cases of hemolytic anemia and immune thrombocytopenia that can be initially classified as idiopathic or primary to be later classified as secondary when associated with infections, medications, neoplasms, or autoimmune diseases. The spectrum of hematologic manifestations in SLE is very broad, including lymphopenia, anemia, thrombocytopenia, or pancytopenia.
  • Platelet system activation is a key event in the pathogenesis of SLE. Circulating immune complexes, anti-phospholipid antibodies and infectious agents such as virus are the main activators of platelets in SLE. Neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are two of the complete blood count parameters. A high NLR is used as an inflammatory marker for different autoimmune diseases. High PLR has been used as a marker for differential diagnosis or prognostic prediction of different diseases such as inflammatory diseases .

Over the past decade, PLR has emerged as a universal laboratory marker for predicting various neoplastic, prothrombotic, and metabolic diseases. PLR fluctuations can be interpreted in the context of the underlying multifaceted immune-inflammatory reactions. Shifts in this parameter correlate positively with other markers of systemic inflammation, particularly with NLR. PLR better predicts clinical outcomes in patients with systemic inflammation than either platelet or lymphocyte count .

  • In previous studies, The major organ systems studied were: renal, hematological, cardiac, pulmonary, hepatic and the central nervous system. The results showed that a high percentage of children had hematological involvement (34%); thrombocytopenia (23%) and hemolytic anemia (20%).
  • JSLE is not rare in Egypt and Africa, representing an important subset that is commonly over looked and requires special attention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  1. Age at enrollment ≤18 years old.
  2. Both sexes
  3. 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.

Exclusion criteria:

  1. Patients with autoimmune diseases other than j SLE
  2. Patients not fulfilling the criteria for diagnosis of SLE
  3. Active infections.
  4. Malignancies.
  5. Lymphoproliferative disorders.
  6. Hematologic diseases
  7. Hepatosplenic diseases and diabetic nephropathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure the absolute neutrophil-to-absolute lymphocyte ratio (NLR).
Time Frame: Baseline
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).
Time Frame: Baseline
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).
Time Frame: Baseline
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)}.
Time Frame: Baseline
Measuring the monocyte distribution width (MDW)} by automated complete blood count ( 2 ml of venous blood will be obtained from the patients )
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Juvenile systemic lupus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings