Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage

September 23, 2020 updated by: RHAbdelrahman, Assiut University
Study aims to evaluate serum galectin-9 in systemic lupus erythematosus patients and determine it's correlation with overall disease process

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by producing large quantities of antibodies directed against self-antigens, particularly double stranded DNA (dsDNA) and small nuclear RNA-binding proteins such as Ro, La, Sm, and nRNP.

SLE-associated autoantibodies and high serum interferon alpha (IFN-α) are two important heritable phenotypes in SLE which are thought to play a role in disease pathogenesis . The most remarkable feature of the anti DNA response is its association with immunopathologic events especially glomerulonephritis . Immune complexes containing DNA can promote the expression of interferon alpha (IFN-alpha) by a specialized population of dendritic cells known as plasmacytoid dendritic cells .

Activation of the type I interferon (IFN) system is associated with disease pathogenesis in SLE, with affected patients typically demonstrating high concentrations of type I IFN proteins . Overexpression of type I IFN-induced genes that includes hundreds of gene transcripts; which is termed interferon signature (IFNGS), has been observed in 60-80% of adults and the majority of children with SLE .

Galectin-9 (Gal-9) is recognized as a novel, easy to measure biomarker for type1 IFN signatures and galectin-9 could aid in clinical decision making in SLE as a marker for disease activity and organ damage.

Galectin-9 is expressed by T cells, macro-phages, fibroblasts, and endothelial cells, its secreted form is barely detected under physiological conditions, it plays an recognizable role in the regulation of inflammation and immune responses by down-regulating pro-inflammatory T cells.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Ages Eligible for Study

16 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinically diagnosed systemic lupus erythematosus patients.

Exclusion Criteria:

  • Individuals with other autoimmune diseases: 1)rheumatoid arthritis patients 2)dermatomyositis 3)scleroderma 4)mixed connective tissue disease

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Systemic lupus erythematosus patients
Evaluation of serum galectin-9 level
Diagnostic test: Serum galectin-9 level
Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group
OTHER: Control group
Evaluation of serum galectin-9 level
Diagnostic test: Serum galectin-9 level
Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.
Time Frame: One year
Compare level of galectin-9 in SLE patients with that of healthy controls
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare galectin-9 in SLE patients with active and inactive renal disease.
Time Frame: One year
Comparison of marker level between patients with active renal disease and patients without a tive renal disease
One year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mona Hussein, Doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 23, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Galectin-9 in SLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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