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

Sponsor
First Affiliated Hospital of Jinan University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05888558
Collaborator
(none)
160
1
10.9
14.7

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Device: Body fluid 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
160 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia
Anticipated Study Start Date :
Jul 4, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Ocular myasthenia gravis group

Ocular myasthenia gravis,age between 18-50 years old

Device: Body fluid diagnosis
miRNAs derived from exosomes in the serum

General myasthenia gravis group

General myasthenia gravis,age between 18-50 years old

Device: Body fluid diagnosis
miRNAs derived from exosomes in the serum

Healthy control group

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

Device: Body fluid diagnosis
miRNAs derived from exosomes in the serum

Outcome Measures

Primary Outcome Measures

  1. A specific miRNA maybe miR-340-5p,miR-106b-5p or miR-27a-3p is a biological marker for diagnosis of OMG [12,2022]

    find some specific miRNA to diagnose OMG.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Jinan University Guangzhou Guangdong China 510632

Sponsors and Collaborators

  • First Affiliated Hospital of Jinan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
XiaoYong Liu, Doctor, First Affiliated Hospital of Jinan University
ClinicalTrials.gov Identifier:
NCT05888558
Other Study ID Numbers:
  • 2021.11JinanU
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by XiaoYong Liu, Doctor, First Affiliated Hospital of Jinan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023