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

NCT05888558 | Unknown

• 1 other identifier: 2021.11JinanU
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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 .

Conditions

Myasthenia Gravis

Keywords

Ocular myasthenia gravis;; miRNA; exosomes

Outcome Measures

Primary Outcomes (1)

• A specific miRNA maybe miR-340-5p，miR-106b-5p or miR-27a-3p is a biological marker for diagnosis of OMG

  find some specific miRNA to diagnose OMG.

  12,2022

Study Arms (3)

Ocular myasthenia gravis group

Ocular myasthenia gravis,age between 18-50 years old

Device: Body fluid diagnosis

General myasthenia gravis group

General myasthenia gravis,age between 18-50 years old

Device: Body fluid diagnosis

Healthy control group

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

Device: Body fluid diagnosis

Interventions

Body fluid diagnosis DEVICE

miRNAs derived from exosomes in the serum

General myasthenia gravis group; Healthy control group; Ocular myasthenia gravis group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

People within age 18-50 years old who is diagnosed with OMG,GMG or healthy people.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Jinan University: lead

Study Sites (1)

First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510632, China

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: June 5, 2023
• Study Start: July 4, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)