Clinical trial NCT04110184: Haematological Indices in Systemic Lupus Erythematosus
Official title: Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Diseases
Systemic Lupus Erythematosus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 42 systemic lupus patients divided into two groups. The first group with active disease and the second group with inactive. There are 42 healthy participants age and sex matched as control group.

Brief summary: The aim of this study is to investigate the value of several hematological indices such as:

* neutrophil-lymphocyte ratio.
* platelet-lymphocyte ratio.
* red blood cell distribution width.
* mean platelet volume (MPV), RDW/platelet ratio.
* neutrophil / C3 ratio.
* All these as biomarkers of activity in systemic lupus erythematosis patients.

Detailed description: Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations of the patients.

The pathogenesis of SLE remains unclear, but environmental triggers and genetic factors contribute to the destruction of immune tolerance systems, the production of immunological lymphocytes, antibodies, and inflammatory cytokines.

The clinical manifestations of SLE range from constitutional symptoms, such as fever, sweats, weight loss, joint pain and skin rashes (including the classic butter fly rash), to more serious features, including the involvement of the central nervous system and kidneys.

However, to make a clinical diagnosis of SLE, The SLICC criteria require either that a patient satisfy at least 4 of 17 criteria, including at least 1 of the 11 clinical criteria and one of the six immunologic criteria, or that the patient has biopsy-proven nephritis compatible with SLE in the presence of antinuclear antibodies (ANA) or anti-double-stranded DNA (dsDNA) antibodies. Patients with higher disease activity often present severer damage of tissues and organs.

SLE is characterized by high heterogeneity, a complex pathophysiology and various clinical manifestations; thus, no test alone is sufficiently sensitive or specific for diagnosis. Active and inactive SLE patients were evaluated according to SLE disease activity index (SLEDAI).There is significant interest in the identification of biomarkers that can predict SLE and quantify disease activity.

Neutrophils and lymphocytes play major roles in inflammatory processes. Under inflammatory conditions, neutrophil and lymphocyte counts undergo temporary changes. Neutrophil to lymphocyte ratio (NLR) is calculated as the absolute count of neutrophils divided by the absolute count of lymphocytes.

As an index of systemic inflammation, NLR has been identified to be a useful index for the differential diagnosis or prognostic prediction of diseases. NLR can be calculated easily and less costly as compared with detection of other inflammatory cytokines that could be used as biomarkers for inflammatory response or disease activity in SLE patient.

The platelet-to-lymphocyte ratio (PLR), red blood cell distribution width (RDW), and similar parameters \[ eg, neutrophil-to-lymphocyte ratio (NLR) and mean platelet volume (MPV) \], which can be easily obtained using peripheral blood parameters, have been regarded as novel, accurate inflammatory biomarkers in many diseases.

MPV is a biomarker of platelet turnover, whereas platelet activation is a marker of inflammation. Previous studies have reported that MPV is correlated with the inflammatory process and disease activity in RA and ankylosing spondylitis, but the relationship between MPV and SLE remains controversial.

Complement system activation, production and partial deposition of complement fragments, and subsequent inflammation all play critical roles in the pathogenesis of SLE. During the complement activation pathway, Complement 3 was at the core position.

Eligibility criteria: Inclusion Criteria:

* 1. SLE patients who fulfills the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (Petri et al., 2012).
* 2. All patients \> 18 years old.

Exclusion Criteria:

* 1. Patients with other autoimmune disease such as: Rheumatoid arthritis (RA), Mixed connective tissue disease (MTCD), Dermatomyositis (DM) and Systemic Sclerosis (SS).
* 2. Patients with malignant diseases.
* 3. Patients with coronary artery disease, cerebrovascular disease, renal and liver diseases.
* 4. Patients with evidence of any concomitant inflammatory disease. Acute infection or chronic inflammatory status.
* 5. Patients with hematological disease or history of blood transfusion in the previous 4 months.

Primary outcomes:
measure: hematological indices and their association with activity in systemic lupus erythematosis patients.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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