Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related DisordersNCT06617962
Evaluation of Two Cell-based Assays for Diagnosing MOG-IgG Associated Disorders
An observational study of Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, run by Huashan Hospital at 1 site in China.
Trial summary
Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders (MOGAD) is a rare inflammatory autoimmune disease. In addition, since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023, there are still no real-world cohort validation studies on this methodology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
- What is being tested?
- CBA method of live cells and fixed cells
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2024to 31 Dec 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individual medical units plan to collect serum samples from clinically suspected MOGAD study participants (150 valid positive cases will be the cutoff for sample collection) between September 2024 and December 2024.
Who may be able to join
- age ≥18 years old, male and female.
- MOGAD is highly suspected.
- Other inflammatory CNS disease control groups include: According to the diagnostic criteria and consensus of various diseases, the diagnosis of multiple sclerosis, Autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome (GBS), Chronic Inflammatory Demyelinating polyradiculopathy (CIDP), Retinal Cerebrovascular disease (SUSAC), POEMS syndrome (POEMS), and neuropathy were confirmed. The monoclonal gammopathy of unknown significance (MGUS), Sarcoidosis and so on.
- The control group of non-inflammatory central nervous system diseases included: Migraine, CSVD, benign cranial hypertension, Glioma with definite diagnosis and no other autoimmune diseases.
- Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means.
- Complete clinical data.
- Informed consent of the patient or his guardian has been obtained.
Who cannot join
- According to the Guidelines for Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases (2021), patients with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 were clearly diagnosed.
- According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis.
- Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid.
- Lack of clinical data.
- Unqualified blood samples.
- The patient\'s informed consent was not obtained.
- Misdiagnosis in the research process went wrong in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Ying Mao, 86 52888828, maoying@fudan.edu.cn
About this study
Official title: Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders (MOGAD) is a rare inflammatory autoimmune disease. In addition, since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023, there are still no real-world cohort validation studies on this methodology. This study intends to establish a large sample cohort with multi-center and paired design. MOG-IgG detection based on live cells and fixed cells was performed on the study participants with high suspicion of MOGAD and the negative control population, to obtain the diagnostic performance parameters and consistency evaluation of the two methodologies, evaluate their clinical diagnostic value, and explore the best individual assay cutoffs for MOG-IgG detection suitable for the diagnosis of MOGAD in China.
Read the detailed description
Study design: A multicenter, observational study to compare the diagnosis performance of two cell-based assays in Chinese patients with idiopathic demyelinating disorders Participants: In this study, serum samples were collected from participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Aim: In this multicenter study, a cell-based assay (CBA) based on cell transfection was proposed to semi-quantitatively detect specific antibodies in human serum samples of study participants with highly suspected clinical manifestations of MOGAD and the control population. Each study participant used two CBA detection methods to detect MOG-IgG at the same time, namely live cell based and fixed cell based, to obtain diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methods, and combined with comprehensive clinical diagnosis to compare their clinical diagnostic value. To explore the individual assay cutoffs for the diagnosis of MOGAD in China.
Total enrollment: participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Time frame: August 1, 2024 to December 1, 2025.
Study protocol:
- This study intends to include participants with a high likelihood of MOGAD, and to simultaneously match a negative control group including inflammatory CNS disease, non-inflammatory CNS disease, and healthy people. Serum samples of the above study participants were detected by CBA method of live cells and fixed cells. According to the comprehensive diagnosis results of clinical experts, the specificity, sensitivity, positive predictive value and negative predictive value of the two methods were compared, and the clinical consistency of the two methods was obtained.
- According to the comprehensive clinical diagnosis results, the consistency of MOG-IgG positive and titer results between active CBA method and fixed CBA method was evaluated.
- According to the comprehensive clinical diagnosis, the diagnostic value of MOGAD in different titers of the two methods was evaluated. To obtain the best individual assay cutoffs of MOGAD diagnosis in this study and improve the specificity of disease diagnosis.
- The proportion of study participants with high suspicion of MOGAD who were diagnosed with MOGAD was counted, and the clinical characteristics of participants in this part of the study were analyzed to explore the correlation between MOG-IgG antibody titers and clinical characteristics, treatment regimen, clinical course, or disease activity.
Official Title Evaluation of the diagnostic value of two cell-based assays for MOG-IGG-associated diseases: a multicenter, paired design observational study Conditions MOG-IgG detection Intervention / Treatment Diagnostic Test: CBA method of live cells and fixed cells.
- Being tested
- CBA method of live cells and fixed cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBA method of live cells and fixed cellsDiagnostic test
- Study participants with high clinical suspicion of MOGAD: 2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. Sensitivity, specificity, positive predictive value and negative predictive value of the two detection methods were calculated according to the detection results and combined with the 2023 MOGAD diagnostic criteria.
- Control group：2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples.
| Study group | Role | What they receive |
|---|---|---|
| Study participants with high clinical suspicion of MOGAD | Based on the "Chinese Expert Consensus on the Diagnosis and Treatment of Myelin Oligodendrocyte Glycoprotein Immunoglobulin MOG-IgG Antibody Associated Diseases" and the "Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria" in2023 Receives: Diagnostic Test: CBA method of live cells and fixed cells | |
| Control group | including 30 participants in the study of other inflammatory CNS diseases, 30 participants in the study of non-inflammatory CNS and 30 participants in the study of healthy people Receives: Diagnostic Test: CBA method of live cells and fixed cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance parameters and consistency evaluation
Each study participant used two cell-based assays to detect MOG-IgG simultaneously, namely live cell based and fixed cell based, to obtain the diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methodologies.
Measured: August 1, 2024 to December 1, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start18 Nov 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related DisordersStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Quan, Huashan Hospital
- Investigators
- Quan Chao, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617962
- Sponsor's protocol ID
- KY2024-1005
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Diagnostic Value of Two Cell-based Assays for MOG-IgG-associated Diseases: A Multicenter, Paired Design Observational Study
- ClinicalTrials.gov ID
- NCT06617962
- Acronym / sponsor ID
- KY2024-1005
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
Anti-myelin oligodendrocyte glycoprotein-IgG-associated disorders (MOGAD) is a rare inflammatory autoimmune disease. In addition, since the international MOGAD group proposed live-cell based assays for MOGAD diagnosis in 2023, there are still no real-world cohort validation studies on this methodology. This study intends to establish a large sample cohort with multi-center and paired design. MOG-IgG detection based on live cells and fixed cells was performed on the study participants with high suspicion of MOGAD and the negative control population, to obtain the diagnostic performance parameters and consistency evaluation of the two methodologies, evaluate their clinical diagnostic value, and explore the best individual assay cutoffs for MOG-IgG detection suitable for the diagnosis of MOGAD in China.
Detailed description
Study design: A multicenter, observational study to compare the diagnosis performance of two cell-based assays in Chinese patients with idiopathic demyelinating disorders Participants: In this study, serum samples were collected from participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Aim: In this multicenter study, a cell-based assay (CBA) based on cell transfection was proposed to semi-quantitatively detect specific antibodies in human serum samples of study participants with highly suspected clinical manifestations of MOGAD and the control population. Each study participant used two CBA detection methods to detect MOG-IgG at the same time, namely live cell based and fixed cell based, to obtain diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methods, and combined with comprehensive clinical diagnosis to compare their clinical diagnostic value. To explore the individual assay cutoffs for the diagnosis of MOGAD in China.
Total enrollment: participants with high clinical suspicion of MOGAD (the number of valid positive cases was 150), and control samples were collected (including 30 participants in other inflammatory CNS disease studies, 30 participants in non-inflammatory CNS studies, and 30 participants in healthy people studies).
Time frame: August 1, 2024 to December 1, 2025.
Study protocol:
- This study intends to include participants with a high likelihood of MOGAD, and to simultaneously match a negative control group including inflammatory CNS disease, non-inflammatory CNS disease, and healthy people. Serum samples of the above study participants were detected by CBA method of live cells and fixed cells. According to the comprehensive diagnosis results of clinical experts, the specificity, sensitivity, positive predictive value and negative predictive value of the two methods were compared, and the clinical consistency of the two methods was obtained.
- According to the comprehensive clinical diagnosis results, the consistency of MOG-IgG positive and titer results between active CBA method and fixed CBA method was evaluated.
- According to the comprehensive clinical diagnosis, the diagnostic value of MOGAD in different titers of the two methods was evaluated. To obtain the best individual assay cutoffs of MOGAD diagnosis in this study and improve the specificity of disease diagnosis.
- The proportion of study participants with high suspicion of MOGAD who were diagnosed with MOGAD was counted, and the clinical characteristics of participants in this part of the study were analyzed to explore the correlation between MOG-IgG antibody titers and clinical characteristics, treatment regimen, clinical course, or disease activity.
Official Title Evaluation of the diagnostic value of two cell-based assays for MOG-IGG-associated diseases: a multicenter, paired design observational study Conditions MOG-IgG detection Intervention / Treatment Diagnostic Test: CBA method of live cells and fixed cells.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study participants with high clinical suspicion of MOGAD | – | Diagnostic Test: CBA method of live cells and fixed cellsBased on the "Chinese Expert Consensus on the Diagnosis and Treatment of Myelin Oligodendrocyte Glycoprotein Immunoglobulin MOG-IgG Antibody Associated Diseases" and the "Diagnosis of myelin oligodendrocyte glycoprotein antibody-associated disease: International MOGAD Panel proposed criteria" in2023 |
| Control group | – | Diagnostic Test: CBA method of live cells and fixed cellsincluding 30 participants in the study of other inflammatory CNS diseases, 30 participants in the study of non-inflammatory CNS and 30 participants in the study of healthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individual medical units plan to collect serum samples from clinically suspected MOGAD study participants (150 valid positive cases will be the cutoff for sample collection) between September 2024 and December 2024.
Key inclusion criteria (7 listed)
- age ≥18 years old, male and female.
- MOGAD is highly suspected.
- Other inflammatory CNS disease control groups include: According to the diagnostic criteria and consensus of various diseases, the diagnosis of multiple sclerosis, Autoimmune encephalitis (except NMDAR encephalitis), Guillain-Barre syndrome (GBS), Chronic Inflammatory Demyelinating polyradiculopathy (CIDP), Retinal Cerebrovascular disease (SUSAC), POEMS syndrome (POEMS), and neuropathy were confirmed. The monoclonal gammopathy of unknown significance (MGUS), Sarcoidosis and so on.
- The control group of non-inflammatory central nervous system diseases included: Migraine, CSVD, benign cranial hypertension, Glioma with definite diagnosis and no other autoimmune diseases.
- Healthy controls include healthy people who have no autoimmune diseases through physical examination and other means.
Key exclusion criteria (7 listed)
- According to the Guidelines for Diagnosis and Treatment of Optic Neuromyelitis Spectrum Diseases (2021), patients with optic Neuromyelitis Spectrum diseases (NMOSD) with positive AQP4 were clearly diagnosed.
- According to the Expert Consensus on the Diagnosis and Treatment of Autoimmune encephalitis in China (2022), the diagnosis was confirmed as NMDAR encephalitis.
- Patients with positive anti-glial fibrillary acidic protein antibody (GFAP-IgG) in serum and/or cerebrospinal fluid.
- Lack of clinical data.
- Unqualified blood samples.
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 |
|---|---|---|
| CBA method of live cells and fixed cells1. Study participants with high clinical suspicion of MOGAD: 2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. Sensitivity, specificity, positive predictive value and negative predictive value of the two detection methods were calculated according to the detection results and combined with the 2023 MOGAD diagnostic criteria. 2. Control group：2mL serum samples were collected for detection. CBA method of live cells and fixed cells was used for all samples. | Diagnostic test | Control group, Study participants with high clinical suspicion of MOGAD |
Primary outcome
diagnostic performance parameters and consistency evaluation
Time frame: August 1, 2024 to December 1, 2025.
Each study participant used two cell-based assays to detect MOG-IgG simultaneously, namely live cell based and fixed cell based, to obtain the diagnostic performance parameters and consistency evaluation (sensitivity, specificity, positive predictive value, negative predictive value) of the two methodologies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Quan Chao principal investigator
Huashan Hospital
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 Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders, run by Huashan Hospital 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Quan (86 13651957283, chao_quan@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance parameters and consistency evaluation (time frame: August 1, 2024 to December 1, 2025.). 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 16 Sep 2026.