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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05888558
Enrollment
160
Registered
2023-06-05
Start date
2023-07-04
Completion date
2024-05-31
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia Gravis

Keywords

Ocular myasthenia gravis;, miRNA, exosomes

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.

Interventions

DEVICEBody fluid diagnosis

miRNAs derived from exosomes in the serum

Sponsors

First Affiliated Hospital of Jinan University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
A specific miRNA maybe miR-340-5p,miR-106b-5p or miR-27a-3p is a biological marker for diagnosis of OMG12,2022find some specific miRNA to diagnose OMG.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026