New Signaling Pathway Targeting Systemic Lupus Erythematosus

NCT03984227 | Unknown

• 1 other identifier: Systemic lupus erythematosus
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Systemic lupus erythematosus is inflammatory autoimmune disease that affects over one million people in the United States. It has a higher prevalence and incidence rate among women compared with men, and among African Americans compared with Caucasians. Despite advances in treatment, standardized mortality rates in SLE remain three times higher than in the general population. The risk of mortality is significantly increased because of renal disease, cardiovascular disease, and infection.The etiology of SLE is multifactorial, with genetic predisposition, environmental factors and epigenetic alterations are involved. However, the molecular mechanisms underlying this systemic autoimmune response remain largely unknown. A key issue in the pathogenesis of lupus is how intracellular antigens become exposed and targeted by the immune system.

Conditions

SLE

Outcome Measures

Primary Outcomes (2)

• determination of the expression levels of GSDMD, NF-kB and miR-379-5p in SLE group and Control group

  GSDMD, NF-kB and miR-379-5p expression levels will be measured using quantitative real time PCR

  6 months

• detection of the relationship between oxidative stress and pyroptosis

  correlation between oxidative stress and pyroptosis and detect if there is relationship between them

  6 months

Study Arms (2)

SLE patient group

SLE diagnosed patients between (18- 60) years old will be enrolled. All participants should met at least four of the American College of Rheumatology criteria (Hochberg, 1997). Disease activity will be assessed in accordance with the SLE Disease Activity Score (SLEDAI 2000 (SLEDAI-2K) (Ward et al., 2000).

Genetic: Taking peripheral blood samples

control group

The control group will include age and sex matched healthy volunteers

Genetic: Taking peripheral blood samples

Interventions

Taking peripheral blood samples GENETIC

quantitative real-time polymerase chain reaction

SLE patient group; control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

\- SLE diagnosed patients between (18- 60) years old will be enrolled. All participants should met at least four of the American College of Rheumatology criteria (Hochberg, 1997). Disease activity will be assessed in accordance with the SLE Disease Activity Score (SLEDAI 2000 (SLEDAI-2K) (Ward et al., 2000).

You may qualify if:

• SLE diagnosed patients between (18- 60) years old will be enrolled.

You may not qualify if:

• Patients with known pre-existing immunological disorders.
• Patients with known pre-existing infection.
• clinical diagnosis of cancer.
• patients diagnosed with concomitant acute myocardial infarction.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• Basiorka AA, McGraw KL, Eksioglu EA, Chen X, Johnson J, Zhang L, Zhang Q, Irvine BA, Cluzeau T, Sallman DA, Padron E, Komrokji R, Sokol L, Coll RC, Robertson AA, Cooper MA, Cleveland JL, O'Neill LA, Wei S, List AF. The NLRP3 inflammasome functions as a driver of the myelodysplastic syndrome phenotype. Blood. 2016 Dec 22;128(25):2960-2975. doi: 10.1182/blood-2016-07-730556. Epub 2016 Oct 13.

  PMID: 27737891 RESULT

• Dang Y, Wang X, Hao Y, Zhang X, Zhao S, Ma J, Qin Y, Chen ZJ. MicroRNA-379-5p is associate with biochemical premature ovarian insufficiency through PARP1 and XRCC6. Cell Death Dis. 2018 Jan 24;9(2):106. doi: 10.1038/s41419-017-0163-8.

  PMID: 29367615 RESULT

• Li J, Xue J, Wang D, Dai X, Sun Q, Xiao T, Wu L, Xia H, Mostofa G, Chen X, Wei Y, Chen F, Quamruzzaman Q, Zhang A, Liu Q. Regulation of gasdermin D by miR-379-5p is involved in arsenite-induced activation of hepatic stellate cells and in fibrosis via secretion of IL-1beta from human hepatic cells. Metallomics. 2019 Feb 20;11(2):483-495. doi: 10.1039/c8mt00321a.

  PMID: 30643918 RESULT

• Magna M, Pisetsky DS. The Role of Cell Death in the Pathogenesis of SLE: Is Pyroptosis the Missing Link? Scand J Immunol. 2015 Sep;82(3):218-24. doi: 10.1111/sji.12335.

  PMID: 26118732 RESULT

• Shi G, Abbott KN, Wu W, Salter RD, Keyel PA. Dnase1L3 Regulates Inflammasome-Dependent Cytokine Secretion. Front Immunol. 2017 May 8;8:522. doi: 10.3389/fimmu.2017.00522. eCollection 2017.

  PMID: 28533778 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Retained

Study Officials

• Ghada M Ezzat, PhD

  Department of Medical Biochemistry, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

• Marwa A Gaber, PhD

  Department of Medical Biochemistry, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman R Mohamed, MD

CONTACT

01064006642; mervatragab224@gmail.com

Manal A Mandour, PhD

CONTACT

041816; manal_mandour@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT LECTURER OF MEDICAL BIOCHEMISTRY

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: June 12, 2019
• Study Start: July 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: April 1, 2021
• Last Updated: June 28, 2019

Record last verified: 2019-05