- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558814
Evaluation of Serum Galectin-9 Level in Systemic Lupus Erythematosus Patients and it's Association With Disease Activity and Organ Damage
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reem Hossam Abd El-rahman, Master
- Phone Number: 01033992163
- Email: medohossamkikii@gmail.com
Study Contact Backup
- Name: Essam Ahmed Mohamed abda, Professor
- Phone Number: 01003889450
- Email: essamabda@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Sponsor
Investigators
- Principal Investigator: Mona Hussein, Doctor
Publications and helpful links
General Publications
- 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. Epub 2019 Aug 12.
- 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.
- 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.
- Ronnblom 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.
- 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.
- 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: 10.1177/0961203319885447. Epub 2019 Oct 29.
- 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):e0227069. doi: 10.1371/journal.pone.0227069. eCollection 2020.
- 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.
- Vilar KM, Pereira MC, Tavares Dantas A, de Melo Rego MJB, Pitta IDR, Pinto Duarte ALB, 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: 10.1371/journal.pone.0223191. eCollection 2019.
- Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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