Urine Exosomes to Identify Biomarkers for LN

Study Overview
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Brief Summary
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Urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Detailed Description
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Lupus nephritis is one of the most common complications of SLE, and its severity is closely related to the prognosis of SLE. The gold standard for diagnosing lupus nephritis depends on the pathological results of a kidney biopsy, which is invasive and may cause some damage to the patient. Exosomes exist in almost all types of body fluids such as serum, urine and cerebrospinal fluid, and contain a variety of genetic materials and proteins secreted by cells, such as miRNA, lnRNA, cirRNA and metabolites, etc., which are potential substances that can be used as biomarkers of diseases discovered in recent years. Urine exosomes are easy to obtain and have no impact on patients' health, making them suitable for study as disease biomarkers for lupus nephritis. In this study, urine exosomes will be extracted from patients with lupus nephritis, healthy controls, and patients with systemic lupus erythematosus without lupus nephritis. Transcriptome and/or metabonomics sequencing of exosomes will be performed to screen for molecules in the urine exosomes of patients with lupus nephritis that are significantly different from those of the other groups.

Official Title
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Identification of Biomarkers for Lupus Nephritis Using Urine Exosomes

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Diagnostic Test: biomarkers detection in different groups


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No history of chronic or serious diseases such as cardiovascular disease, liver disease, kidney disease, respiratory disease, blood disease, lymphatic disease, endocrine disease, immune disease, mental disease, neuromuscular disease, gastrointestinal system disease, etc. General health condition is good; Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemical examination, coagulation function examination), electrocardiogram, and the results show normal or abnormal without clinical significance Exclusion Criteria: Other rheumatic immune disease; Abnormal liver and kidney function; Acute and chronic infectious diseases.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy control (HC)<br>healthy control | Diagnostic Test: biomarkers detection in different groups<br>* Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups<br>|
| Systemic Lupus Erythematosus (SLE)<br>Systemic Lupus Erythematosus | Diagnostic Test: biomarkers detection in different groups<br>* Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups<br>|
| lupus nephritis (LN)<br>lupus nephritis | Diagnostic Test: biomarkers detection in different groups<br>* Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific molecule levels in urine exosomes | Molecule like miRNAs were determined in urine exosomes of different groups and the following validation will determine which molecule can be served as biomarkers of lupus nephritis | 2 weeks |