Urine Exosomes to Identify Biomarkers for LN

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-02

Study Completion Date

2021-08-31

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.

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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.

Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy control (HC)

healthy control

biomarkers detection in different groups

Intervention Type DIAGNOSTIC_TEST

Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups

Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

biomarkers detection in different groups

Intervention Type DIAGNOSTIC_TEST

Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups

lupus nephritis (LN)

lupus nephritis

biomarkers detection in different groups

Intervention Type DIAGNOSTIC_TEST

Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups

Interventions

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biomarkers detection in different groups

Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups

Intervention Type DIAGNOSTIC_TEST

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