Autophagy in Systemic Lupus Erythematosus
Autophagy Genes and Interleukin-10 in Systemic Lupus Erythematosus Patients
1 other identifier
observational
100
0 countries
N/A
Brief Summary
Systemic lupus erythematosus is systemic autoimmune disease characterized by a wide range of clinical manifestations, from skin and mucosal lesions to severe injuries in the central nervous system, kidneys and other organs. The presence of high titres of autoantibodies against nuclear components, immune complexes deposition, complement deficiency and lymphocytes infiltration in affected tissues, which causes tissue and organ damage are the main characteristics of the disease. Nowadays, many studies elucidate the essential role of autophagy in the occurrence, development and severity of systemic lupus erythematosus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 12, 2018
July 1, 2018
1 year
June 22, 2018
July 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the expression of autophagy genes in systemic lupus erythematosus patients group and control group
the expression of autophagy genes will be measured by real time polymerase chain reaction
Baseline and 6 months
Study Arms (2)
patients
take 5 ml blood for isolation of peripheral blood mono-nuclear cells then extraction of Ribonucleic acid (RNA) to determine the expression of autophagy genes by real time polymerase chain reaction (real time PCR)
control
take 5 ml blood for isolation of peripheral blood mono-nuclear cells then extraction of RNA to determine the expression of autophagy genes real time polymerase chain reaction
Interventions
real time PCR will be used for determination of expression of autophagy genes
Eligibility Criteria
SLE patients are evaluated according to the SLE disease activity index 2000 (SLEDAI) and classified into two groups, one having active disease and the other group with inactive disease
You may qualify if:
- patients who fulfilled at least four criteria of systemic lupus erythematosus according to American College of Rheumatology
You may not qualify if:
- Pregnancy or lactation.
- coexistence of other autoimmune diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
Ciccacci C, Perricone C, Alessandri C, Latini A, Politi C, Delunardo F, Pierdominici M, Conti F, Novelli G, Ortona E, Borgiani P. Evaluation of ATG5 polymorphisms in Italian patients with systemic lupus erythematosus: contribution to disease susceptibility and clinical phenotypes. Lupus. 2018 Aug;27(9):1464-1469. doi: 10.1177/0961203318776108. Epub 2018 May 14.
PMID: 29759048BACKGROUNDKlionsky DJ. Autophagy: from phenomenology to molecular understanding in less than a decade. Nat Rev Mol Cell Biol. 2007 Nov;8(11):931-7. doi: 10.1038/nrm2245.
PMID: 17712358BACKGROUNDZhang Y, Morgan MJ, Chen K, Choksi S, Liu ZG. Induction of autophagy is essential for monocyte-macrophage differentiation. Blood. 2012 Mar 22;119(12):2895-905. doi: 10.1182/blood-2011-08-372383. Epub 2012 Jan 5.
PMID: 22223827BACKGROUNDDang J, Li J, Xin Q, Shan S, Bian X, Yuan Q, Liu N, Ma X, Li Y, Liu Q. Gene-gene interaction of ATG5, ATG7, BLK and BANK1 in systemic lupus erythematosus. Int J Rheum Dis. 2016 Dec;19(12):1284-1293. doi: 10.1111/1756-185X.12768. Epub 2015 Sep 30.
PMID: 26420661BACKGROUNDZhu L, Wang H, Wu Y, He Z, Qin Y, Shen Q. The Autophagy Level Is Increased in the Synovial Tissues of Patients with Active Rheumatoid Arthritis and Is Correlated with Disease Severity. Mediators Inflamm. 2017;2017:7623145. doi: 10.1155/2017/7623145. Epub 2017 Feb 1.
PMID: 28255205BACKGROUNDTeruel M, Alarcon-Riquelme ME. The genetic basis of systemic lupus erythematosus: What are the risk factors and what have we learned. J Autoimmun. 2016 Nov;74:161-175. doi: 10.1016/j.jaut.2016.08.001. Epub 2016 Aug 10.
PMID: 27522116BACKGROUNDZhou XJ, Lu XL, Lv JC, Yang HZ, Qin LX, Zhao MH, Su Y, Li ZG, Zhang H. Genetic association of PRDM1-ATG5 intergenic region and autophagy with systemic lupus erythematosus in a Chinese population. Ann Rheum Dis. 2011 Jul;70(7):1330-7. doi: 10.1136/ard.2010.140111.
PMID: 21622776BACKGROUNDGodsell J, Rudloff I, Kandane-Rathnayake R, Hoi A, Nold MF, Morand EF, Harris J. Clinical associations of IL-10 and IL-37 in systemic lupus erythematosus. Sci Rep. 2016 Oct 6;6:34604. doi: 10.1038/srep34604.
PMID: 27708376BACKGROUNDLopez P, Alonso-Perez E, Rodriguez-Carrio J, Suarez A. Influence of Atg5 mutation in SLE depends on functional IL-10 genotype. PLoS One. 2013 Oct 18;8(10):e78756. doi: 10.1371/journal.pone.0078756. eCollection 2013.
PMID: 24205307BACKGROUNDWard MM, Marx AS, Barry NN. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol. 2000 Mar;27(3):664-70.
PMID: 10743805BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
June 22, 2018
First Posted
July 12, 2018
Study Start
July 1, 2019
Primary Completion
July 1, 2020
Study Completion
December 1, 2020
Last Updated
July 12, 2018
Record last verified: 2018-07