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Autophagy in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03583853
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ayat Mostafa, Assiut University

Tracking Information
First Submitted Date June 22, 2018
First Posted Date July 12, 2018
Last Update Posted Date July 12, 2018
Estimated Study Start Date July 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2018)
Change in the expression of autophagy genes in systemic lupus erythematosus patients group and control group [ Time Frame: Baseline and 6 months ]
the expression of autophagy genes will be measured by real time polymerase chain reaction
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autophagy in Systemic Lupus Erythematosus
Official Title Autophagy Genes and Interleukin-10 in Systemic Lupus Erythematosus Patients
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.
Detailed Description

Autophagy is a highly conserved lysosome-mediated catabolic process. It can remove unwanted cytoplasmic components, such as long-lived and/or misfolded proteins, damaged organelles, playing an important role in maintaining cellular homeostasis and cell survival in stress conditions, such as nutrient deprivation and hypoxia.

Recently, Autophagy is implicated in nearly all steps of both innate and adaptive immune responses, including neutrophil extracellular trap and inflammasome formation, pathogen recognition, lymphocyte and monocyte development and function, antigen processing and presentation, type I interferon production and inflammatory regulation, thus playing an important part in maintaining the balance of immune system.

Autophagy is divided into three major types: macroautophagy, microautophagy, and chaperone-mediated autophagy, with macroautophagy being the most investigated and understood. Disturbances in autophagy have been implicated in chronic inflammatory diseases and several autoimmune diseases, including Systemic lupus erythematosus, multiple sclerosis, Crohn's disease and rheumatoid arthritis.

Several regulatory factors that may play key roles in autophagy processes have been discovered in recent years, such as beclin1, which is the key regulatory factor in the autophagy startup process, microtubule-associated protein-light chain 3, autophagy-related gene 5, which are components of autophagosomes.

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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
Condition Systemic Lupus Erythematosus
Intervention Device: real time PCR
real time PCR will be used for determination of expression of autophagy genes
Study Groups/Cohorts
  • 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)
    Intervention: Device: 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
    Intervention: Device: real time PCR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 11, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients who fulfilled at least four criteria of systemic lupus erythematosus according to American College of Rheumatology

Exclusion Criteria:

  • Pregnancy or lactation.
  • coexistence of other autoimmune diseases.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Mohamed Ali el-feky, prof 00201223971310 mohelfeky@hotmail.com
Contact: Mohamed Saad Badary, prof 00201000103328 Dtn_diatechnology@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03583853
Other Study ID Numbers amkmm
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ayat Mostafa, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2018