Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Haematological Indices in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110184
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
AA Mohamed, Assiut University

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.

Condition or disease Intervention/treatment
Rheumatic Diseases Systemic Lupus Erythematosus Other: Systemic lupus erythematosus disease activity index (SLEDAI)

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Haematological Indices in Systemic Lupus Erythematosus and Their Association With Disease Activity
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort Intervention/treatment
active systemic lupus erythematosus Other: Systemic lupus erythematosus disease activity index (SLEDAI)
The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease

inactive systemic lupus erythematosus Other: Systemic lupus erythematosus disease activity index (SLEDAI)
The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease




Primary Outcome Measures :
  1. hematological indices and their association with activity in systemic lupus erythematosis patients. [ Time Frame: baseline ]
    investigate the value of several hematological indices and their association with activity in systemic lupus erythematosis patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110184


Contacts
Layout table for location contacts
Contact: Alaa Atef, Resident doctor 01114341538 alaa.atef_2012@yahoo.com

Sponsors and Collaborators
Assiut University
Publications of Results:
Other Publications:
Gorial FI (2018) A Clinical Utility of Neutrophil Lymphocyte Ratio as A Prognostic Indicator of Systemic Lupus Erythematosus Disease Activity. J. Pharm. Sci. & Res. 10(3) : 637-639.

Layout table for additonal information
Responsible Party: AA Mohamed, doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04110184    
Other Study ID Numbers: Haematological indices
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Lupus Erythematosus, Systemic
Collagen Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases