Myasthenia GravisNCT05888558
Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia Gravis
An observational study of Myasthenia Gravis, run by First Affiliated Hospital of Jinan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Body fluid diagnosis
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2023to 31 May 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: People within age 18-50 years old who is diagnosed with OMG,GMG or healthy people.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510632
About this study
Official title: Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia
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 .
Read the 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
- Being tested
- Body fluid diagnosis
- Keywords
- Ocular myasthenia gravis;, miRNA, exosomes
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body fluid diagnosisDevice
miRNAs derived from exosomes in the serum
| Study group | Role | What they receive |
|---|---|---|
| Ocular myasthenia gravis group | Ocular myasthenia gravis,age between 18-50 years old Receives: Device: Body fluid diagnosis | |
| General myasthenia gravis group | General myasthenia gravis,age between 18-50 years old Receives: Device: Body fluid diagnosis | |
| Healthy control group | people who are healthy without any systemic diseases，18-50 years old Receives: Device: Body fluid diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start4 Jul 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Jinan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XiaoYong Liu, First Affiliated Hospital of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888558
- Sponsor's protocol ID
- 2021.11JinanU
- Status last verified
- May 2023
- First submitted
- 4 Nov 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Serum Exosomal miRNA as a Biomarker for Ocular Muscle Myasthenia
- ClinicalTrials.gov ID
- NCT05888558
- Acronym / sponsor ID
- 2021.11JinanU
- Conditions
- Myasthenia Gravis
- Keywords
- Ocular myasthenia gravis;, miRNA, exosomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Jinan UniversityUniversity, hospital or other
- Study start
- 4 Jul 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ocular myasthenia gravis group | – | Device: Body fluid diagnosisOcular myasthenia gravis,age between 18-50 years old |
| General myasthenia gravis group | – | Device: Body fluid diagnosisGeneral myasthenia gravis,age between 18-50 years old |
| Healthy control group | – | Device: Body fluid diagnosispeople who are healthy without any systemic diseases，18-50 years old |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- People within age 18-50 years old who is diagnosed with OMG,GMG or healthy people.
Key inclusion criteria (2 listed)
- Clinical manifestations: fluctuating myasthenia;
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body fluid diagnosismiRNAs derived from exosomes in the serum | Device | General myasthenia gravis group, Healthy control group, Ocular myasthenia gravis group |
Primary outcome
A specific miRNA maybe miR-340-5p，miR-106b-5p or miR-27a-3p is a biological marker for diagnosis of OMG
Time frame: 12,2022
find some specific miRNA to diagnose OMG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by First Affiliated Hospital of Jinan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A specific miRNA maybe miR-340-5p，miR-106b-5p or miR-27a-3p is a biological marker for diagnosis of OMG (time frame: 12,2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.