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Trial Title:
Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia Gravis
NCT ID:
NCT05888558
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
Ocular myasthenia gravis;
miRNA
exosomes
Study type:
Observational [Patient Registry]
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Device
Intervention name:
Body fluid diagnosis
Description:
miRNAs derived from exosomes in the serum
Arm group label:
General myasthenia gravis group
Arm group label:
Healthy control group
Arm group label:
Ocular myasthenia gravis group
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.
Criteria for eligibility:
Study pop:
People within age 18-50 years old who is diagnosed with OMG,GMG or healthy people.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
First Affiliated Hospital of Jinan University
Address:
City:
Guangzhou
Zip:
510632
Country:
China
Start date:
July 4, 2023
Completion date:
May 31, 2024
Lead sponsor:
Agency:
First Affiliated Hospital of Jinan University
Agency class:
Other
Source:
First Affiliated Hospital of Jinan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888558
