Urine Exosomes to Identify Biomarkers for LN

NCT04894695 | Unknown

• 1 other identifier: urine exo-LN
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

healthy control (HC)

healthy control

Diagnostic Test: biomarkers detection in different groups

Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Diagnostic Test: biomarkers detection in different groups

lupus nephritis (LN)

lupus nephritis

Diagnostic Test: biomarkers detection in different groups

Interventions

biomarkers detection in different groups 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); healthy control (HC); lupus nephritis (LN)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• Other rheumatic immune disease;
• Abnormal liver and kidney function;
• Acute and chronic infectious diseases.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 021, China

RECRUITING

Related Publications (1)

• Zhao Y, Wei W, Liu ML. Extracellular vesicles and lupus nephritis - New insights into pathophysiology and clinical implications. J Autoimmun. 2020 Dec;115:102540. doi: 10.1016/j.jaut.2020.102540. Epub 2020 Sep 4.

  PMID: 32893081 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Liangjing Lu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huijing Huang

CONTACT

86-18217720058; fangfeijin90@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 20, 2021
• Study Start: August 2, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 31, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)