Urine Exosomes to Identify Biomarkers for LN

July 27, 2021 updated by: RenJi Hospital

Identification of Biomarkers for Lupus Nephritis Using Urine Exosomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 021
        • Recruiting
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy control (HC)
healthy control
Diagnostic test: 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
Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
Diagnostic test: 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
lupus nephritis (LN)
lupus nephritis
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
specific molecule levels in urine exosomes
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Liangjing Lu, Renji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2020

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

May 15, 2021

First Submitted That Met QC Criteria

May 15, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • urine exo-LN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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