Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia Gravis

NCT ID: NCT05888558

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2024-05-31

Brief Summary

Ocular muscle myasthenia gravis (Ocular Myasthenia Gravis, OMG) has a high incidence and is difficult to diagnose. It is very necessary to find specific diagnostic indicators for OMG. By collecting peripheral blood of OMG, systemic myasthenia gravis and healthy people, extract miRNAs derived from exosomes in the serum and perform high-throughput sequencing, then use bioinformatics analysis methods to screen specifically expressed miRNAs as biomarkers for OMG diagnosis .

Detailed Description

Part I: (1) Collect peripheral blood samples from patients with early-onset OMG, early-onset GMG and healthy subjects of age and sex matched who have been diagnosed for the first time and have not undergone any drug treatment. There are 6 cases in each group. Extract the secretion miRNA in serum and conduct high-throughput sequencing. Analyze and compare the differential expression miRNAs between OMG, GMG and healthy control groups by edgeR. The standard of differential expression is set as | logFC |>1, p<0.05. Use miRTarBase, TargetScan, and miRDB to predict target genes for differentially expressed miRNAs. Conduct GO enrichment and KEGG signaling pathway analysis on target genes. The STRING tool is used to construct the target gene protein interaction network (PPI). According to the importance of the target gene calculated by the maximum population concentration ratio (MCC) method, the top ten genes (hub genes) are selected and analyzed.

(2) Randomly collect peripheral blood samples from patients with early-onset OMG, early-onset GMG, and age-matched healthy subjects, with 10 samples in each group. The differentially expressed miRNAs obtained during the sequencing phase were validated using real-time fluorescence quantification (RT-qPCR). Construct a receiver operating characteristic curve (ROC) curve to evaluate the diagnostic efficacy of the identified miRNA.

Conditions

Myasthenia Gravis

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Ocular myasthenia gravis group

Ocular myasthenia gravis,age between 18-50 years old

Body fluid diagnosis

Intervention Type: DEVICE

miRNAs derived from exosomes in the serum

General myasthenia gravis group

General myasthenia gravis,age between 18-50 years old

Body fluid diagnosis

Intervention Type: DEVICE

miRNAs derived from exosomes in the serum

Healthy control group

people who are healthy without any systemic diseases，18-50 years old

Body fluid diagnosis

Intervention Type: DEVICE

miRNAs derived from exosomes in the serum

Interventions

Body fluid diagnosis

miRNAs derived from exosomes in the serum

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Clinical manifestations: fluctuating myasthenia;

• neostigmine test positive; ③ AChR-Ab, Musk-Ab, LRP4-Ab antibodies positive; ④repetitive nerve stimulation or single fiber EMG Positive (comply with the first one of the above diagnostic criteria and any one of the other three, and at the same time exclude ophthalmoplegia caused by other diseases, the diagnosis can be confirmed).

Exclusion Criteria

①Combined with other autoimmune diseases or other inflammatory diseases; ②Patients with tumorous diseases;

• Received targeted biologics, intravenous gamma globulin, plasma exchange therapy within three months before treatment; ④Pregnancy Status or lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role: lead

Responsible Party

XiaoYong Liu

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021.11JinanU

Identifier Type: -

Identifier Source: org_study_id