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Urine Exosomes to Identify Biomarkers for LN

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Unknown

Conditions

Lupus Nephritis

Treatments

Diagnostic Test: biomarkers detection in different groups

Study type

Observational

Funder types

Other

Identifiers

NCT04894695
urine exo-LN

Details and patient eligibility

About

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.

Full description

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.

Enrollment

400 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

400 participants in 3 patient groups

healthy control (HC)
Description:
healthy control
Treatment:
Diagnostic Test: biomarkers detection in different groups
Systemic Lupus Erythematosus (SLE)
Description:
Systemic Lupus Erythematosus
Treatment:
Diagnostic Test: biomarkers detection in different groups
lupus nephritis (LN)
Description:
lupus nephritis
Treatment:
Diagnostic Test: biomarkers detection in different groups

Trial contacts and locations

1

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Central trial contact

Huijing Huang

Data sourced from clinicaltrials.gov

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