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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04558814
• Other study ID #: Galectin-9 in SLE
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Reem Hossam Abd El-rahman, Master
• Phone: 01033992163
• Email: medohossamkikii[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study aims to evaluate serum galectin-9 in systemic lupus erythematosus patients and determine it's correlation with overall disease process

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (10)

Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.11 — View Citation

Catalina MD, Bachali P, Geraci NS, Grammer AC, Lipsky PE. Gene expression analysis delineates the potential roles of multiple interferons in systemic lupus erythematosus. Commun Biol. 2019 Apr 23;2:140. doi: 10.1038/s42003-019-0382-x. eCollection 2019. — View Citation

Chen HY, Wu YF, Chou FC, Wu YH, Yeh LT, Lin KI, Liu FT, Sytwu HK. Intracellular Galectin-9 Enhances Proximal TCR Signaling and Potentiates Autoimmune Diseases. J Immunol. 2020 Mar 1;204(5):1158-1172. doi: 10.4049/jimmunol.1901114. Epub 2020 Jan 22. — View Citation

Kudose S, Santoriello D, Bomback AS, Stokes MB, D'Agati VD, Markowitz GS. Sensitivity and Specificity of Pathologic Findings to Diagnose Lupus Nephritis. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1605-1615. doi: 10.2215/CJN.01570219. Epub 2019 Oct 25. — View Citation

Matsuoka N, Fujita Y, Temmoku J, Furuya MY, Asano T, Sato S, Matsumoto H, Kobayashi H, Watanabe H, Suzuki E, Kozuru H, Yastuhashi H, Migita K. Galectin-9 as a biomarker for disease activity in systemic lupus erythematosus. PLoS One. 2020 Jan 27;15(1):e022 — View Citation

Matta B, Barnes BJ. Coordination between innate immune cells, type I IFNs and IRF5 drives SLE pathogenesis. Cytokine. 2020 Aug;132:154731. doi: 10.1016/j.cyto.2019.05.018. Epub 2019 May 23. — View Citation

Muslimov IA, Iacoangeli A, Eom T, Ruiz A, Lee M, Stephenson S, Ginzler EM, Tiedge H. Neuronal BC RNA Transport Impairments Caused by Systemic Lupus Erythematosus Autoantibodies. J Neurosci. 2019 Sep 25;39(39):7759-7777. doi: 10.1523/JNEUROSCI.1657-18.2019 — View Citation

Petri M, Orbai AM, Alarcón GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sánchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth — View Citation

Rönnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019 Aug 13;6(1):e000270. doi: 10.1136/lupus-2018-000270. eCollection 2019. Review. — View Citation

Vilar KM, Pereira MC, Tavares Dantas A, de Melo Rêgo MJB, Pitta IDR, Pinto Duarte ÂLB, da Rocha Pitta MG. Galectin-9 gene (LGALS9) polymorphisms are associated with rheumatoid arthritis in Brazilian patients. PLoS One. 2019 Oct 10;14(10):e0223191. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.	Compare level of galectin-9 in SLE patients with that of healthy controls	One year
Secondary	compare galectin-9 in SLE patients with active and inactive renal disease.	Comparison of marker level between patients with active renal disease and patients without a tive renal disease	One year