Detection Autoantibody of Myasthenia GravisNCT05219097
The Specificity, Sensitivity and Clinical Correlation of CBA, RIPA and ELISA in Detecting AChR and MuSK IgG of Myasthenia Gravis
An observational study of Detection Autoantibody of Myasthenia Gravis, run by Tianjin Medical University General Hospital at 2 sites in China.
Trial summary
Myasthenia gravis (MG) is a neuromuscular junction (NMJ) disorder mediated by autoantibodies against AChR, MuSK or other autoantigens located at the post synaptic membrane of the neuromuscular junction. Read more about this study
- Who is it for?
- Ages 1 year to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Detection Autoantibody of Myasthenia Gravis
- What is being tested?
- CBA Assay
- How many people
- 2,663 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- 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 1 year to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with suspected MG, 1-90 years of age.
Who may be able to join
- Patients with compatible clinical features of weakness of skeletal muscles, including ptosis, diplopia, dysphonia, dysphagia, or limb weakness.
- Patients need to do the diagnosis of MG, requiring serum autoantibody, electrophysiological, pharmacological neostigmine test, thymic computed tomography (CT) and magnetic resonance imaging (MRI), etc in the diagnostic evaluation of MG.
Who cannot join
- Patients with uncertain diagnoses or incomplete clinical data for data analysis.
- Patients with abnormal serum samples, such as hemolysis or lipemia, which will affect the detection base value and the final interpretation of CBA, RIPA and ELISA.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tiantan Hospital
Beijing, 100070
Tianjin Medical University General Hospital
Tianjin, 30000
About this study
Official title: Comparison of the Specificity, Sensitivity and Clinical Correlation of CBA, RIPA and ELISA Assay in Detecting AChR and MuSK IgG of Myasthenia Gravis: a National Multicenter Study
Myasthenia gravis (MG) is a neuromuscular junction (NMJ) disorder mediated by autoantibodies against AChR, MuSK or other autoantigens located at the post synaptic membrane of the neuromuscular junction. Presence of autoantibodies specific for AChR or MuSK can establish diagnosis in conjunction with clinical presentations. In most established guidelines for the diagnosis and treatment of myasthenia gravis, determination of AChR and MuSK antibodies has been recommended. Radioimmunoprecipitation assay (RIPA), enzyme-linked immunosorbent assay (ELISA), and cell-based assay (CBA) are all commercially available and have been adopted for autoantibody detection by most referring neurologists. At present, specificity and sensitivity of these methods have not been compared in large cohorts within a context of stringent quality control. As a consequence, there are no national or international consensus regarding selection of methods and interpretation of results, resulting in challenges to neurologists managing these patients. To this end, the investigators proposed to conduct a multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA and ELISA assays to detect AChR and MuSK antibodies.
Read the detailed description
Participants: patients with suspected MG
Aim: the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
Study design: A multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA, and ELISA assays in detecting AChR and MuSK antibodies.
Total enrollment: 3000 patients with suspected MG will be enrolled.
Time frame: The enrollment time of this trial is 21 months, and the entire study period is about 24 months.
Reagent resource: 1. Acetylcholine receptor autoantibody RIA kit: RSR limited, recommended cut-off value=0.5 nmol/L.
- Acetylcholine receptor autoantibody CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.
- Acetylcholine receptor autoantibody ELISA kit: RSR limited; recommended cut-off value=0.45 nmol/L.
- Muscle-specific tyrosine kinase RIA kit: RSR limited, recommended cut-off value =0.05 nmol/L.
- Muscle-specific tyrosine kinase CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.
- Muscle-specific tyrosine kinase ELISA kit: IBL, recommended cut-off value=0.4 U/ml.
Groups: The samples were divided into 3 groups according to the detected methods: CBA group, RIPA group and ELISA group.
Study protocol: 1. When patients suspected of MG matched up with the inclusion and exclusion criteria, the serum sample of each patient would be divided into equal aliquots and randomly assigned to the CBA, ELISA, and RIPA testing laboratories for detection.
- All patient's information will be masked and monitored by members of ethics committees. Serum specimens from participants will be renumbered without any clinical information before doing the tests to be investigated. According to the standard procedure of kits, the operator in laboratories to perform the CBA, ELISA, or RIPA will complete the detection of AChR and MuSK antibodies of the enrolled participants' serum, and record the original value, control, or reference value.
- Each MG center will provide the clinical diagnosis results of the enrolled patients, treatment and follow up information of the participants. The diagnosis of MG and the tests to be investigated will be double blindly done.
- The data statistics, analysis, and summary of the project are operated by an independent third-party statistic team.
Evaluation indicators: Evaluate the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
- Being tested
- CBA Assay
- Keywords
- Cell-based assay, Radioimmunoprecipitation assay (RIPA), Enzyme-linked immunosorbent assay (ELISA), Autoantibody determination, Myasthenia gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBA AssayDiagnostic test
Also called ELISA Assay, RIPA Assay
Comparsion of specificity, sensitivity and clinical correlation of CBA, ELISA and RIPA assay in autoantibodies detection of myasthenia gravis
| Study group | Role | What they receive |
|---|---|---|
| Cell Based Assay (CBA) | Use AChR/MuSK Ab CBA Kit (Tianjin New Terrain Biological Technology Co., Ltd, China) to detect AChR and MuSK Ab of myasthenia gravis Receives: Diagnostic Test: CBA Assay | |
| RIPA Assay | Use AChR and MuSK Ab radioimmunoassay kit (RSR Limited, UK) to detect AChR and MuSK Ab of myasthenia gravis Receives: Diagnostic Test: CBA Assay | |
| ELISA Assay | Use AChR Ab ELISA Kit (RSR Limited, UK) and MuSK ELISA kit (IBL Limited, Germany) to detect AChR and MuSK Ab of myasthenia gravis Receives: Diagnostic Test: CBA Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparsion of the specificity, sensitivity and clinical correlation
Comparsion the specificity,sensitivity and clinical correlation of CBA, RIPA and ELISA assay in autoantibodies detection of myasthenia gravis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Detection Autoantibody of 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Dong Shi, Tianjin Medical University General Hospital
- Investigators
- Fu-Dong Shi, MD, Ph.D, Study chair, Beijing Tiantan Hospital,Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219097
- Sponsor's protocol ID
- IRB2021-YX-260-01
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Z, Zhang C, Chang T, Zhang X, Yang H, Gao F, Feng J, Liu H, Chen S, Wang L, Yang C, Li H, Pan Y, Palace J, Shi FD; SCREAM Study Investigators. A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study. Lancet Reg Health West Pac. 2023 Jul 19;38:100846. doi: 10.1016/j.lanwpc.2023.100846. eCollection 2023 Sep.
PubMed 37554174
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Specificity, Sensitivity and Clinical Correlation of CBA, RIPA and ELISA Assay in Detecting AChR and MuSK IgG of Myasthenia Gravis: a National Multicenter Study
- ClinicalTrials.gov ID
- NCT05219097
- Acronym / sponsor ID
- IRB2021-YX-260-01
- Keywords
- Cell-based assay, Radioimmunoprecipitation assay (RIPA), Enzyme-linked immunosorbent assay (ELISA), Autoantibody determination, Myasthenia gravis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,663 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Feb 2022 (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.
Myasthenia gravis (MG) is a neuromuscular junction (NMJ) disorder mediated by autoantibodies against AChR, MuSK or other autoantigens located at the post synaptic membrane of the neuromuscular junction. Presence of autoantibodies specific for AChR or MuSK can establish diagnosis in conjunction with clinical presentations. In most established guidelines for the diagnosis and treatment of myasthenia gravis, determination of AChR and MuSK antibodies has been recommended. Radioimmunoprecipitation assay (RIPA), enzyme-linked immunosorbent assay (ELISA), and cell-based assay (CBA) are all commercially available and have been adopted for autoantibody detection by most referring neurologists. At present, specificity and sensitivity of these methods have not been compared in large cohorts within a context of stringent quality control. As a consequence, there are no national or international consensus regarding selection of methods and interpretation of results, resulting in challenges to neurologists managing these patients. To this end, the investigators proposed to conduct a multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA and ELISA assays to detect AChR and MuSK antibodies.
Detailed description
Participants: patients with suspected MG
Aim: the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
Study design: A multicenter, double-blind, prospective study to compare the sensitivity and specificity of CBA, RIPA, and ELISA assays in detecting AChR and MuSK antibodies.
Total enrollment: 3000 patients with suspected MG will be enrolled.
Time frame: The enrollment time of this trial is 21 months, and the entire study period is about 24 months.
Reagent resource: 1. Acetylcholine receptor autoantibody RIA kit: RSR limited, recommended cut-off value=0.5 nmol/L.
- Acetylcholine receptor autoantibody CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.
- Acetylcholine receptor autoantibody ELISA kit: RSR limited; recommended cut-off value=0.45 nmol/L.
- Muscle-specific tyrosine kinase RIA kit: RSR limited, recommended cut-off value =0.05 nmol/L.
- Muscle-specific tyrosine kinase CBA kit: Tianjin New Terrain Biological Technology Co., Ltd; recommended cut-off value =1:10.
- Muscle-specific tyrosine kinase ELISA kit: IBL, recommended cut-off value=0.4 U/ml.
Groups: The samples were divided into 3 groups according to the detected methods: CBA group, RIPA group and ELISA group.
Study protocol: 1. When patients suspected of MG matched up with the inclusion and exclusion criteria, the serum sample of each patient would be divided into equal aliquots and randomly assigned to the CBA, ELISA, and RIPA testing laboratories for detection.
- All patient's information will be masked and monitored by members of ethics committees. Serum specimens from participants will be renumbered without any clinical information before doing the tests to be investigated. According to the standard procedure of kits, the operator in laboratories to perform the CBA, ELISA, or RIPA will complete the detection of AChR and MuSK antibodies of the enrolled participants' serum, and record the original value, control, or reference value.
- Each MG center will provide the clinical diagnosis results of the enrolled patients, treatment and follow up information of the participants. The diagnosis of MG and the tests to be investigated will be double blindly done.
- The data statistics, analysis, and summary of the project are operated by an independent third-party statistic team.
Evaluation indicators: Evaluate the specificity, sensitivity, and clinical correlation of AChR and MuSK IgG detection through the CBA, ELISA, and RIPA methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cell Based Assay (CBA) | – | Diagnostic Test: CBA AssayUse AChR/MuSK Ab CBA Kit (Tianjin New Terrain Biological Technology Co., Ltd, China) to detect AChR and MuSK Ab of myasthenia gravis |
| RIPA Assay | – | Diagnostic Test: CBA AssayUse AChR and MuSK Ab radioimmunoassay kit (RSR Limited, UK) to detect AChR and MuSK Ab of myasthenia gravis |
| ELISA Assay | – | Diagnostic Test: CBA AssayUse AChR Ab ELISA Kit (RSR Limited, UK) and MuSK ELISA kit (IBL Limited, Germany) to detect AChR and MuSK Ab of myasthenia gravis |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected MG, 1-90 years of age.
Key inclusion criteria (2 listed)
- Patients with compatible clinical features of weakness of skeletal muscles, including ptosis, diplopia, dysphonia, dysphagia, or limb weakness.
- Patients need to do the diagnosis of MG, requiring serum autoantibody, electrophysiological, pharmacological neostigmine test, thymic computed tomography (CT) and magnetic resonance imaging (MRI), etc in the diagnostic evaluation of MG.
Key exclusion criteria (2 listed)
- Patients with uncertain diagnoses or incomplete clinical data for data analysis.
- Patients with abnormal serum samples, such as hemolysis or lipemia, which will affect the detection base value and the final interpretation of CBA, RIPA and ELISA.
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 AssayAlso: ELISA Assay, RIPA AssayComparsion of specificity, sensitivity and clinical correlation of CBA, ELISA and RIPA assay in autoantibodies detection of myasthenia gravis | Diagnostic test | Cell Based Assay (CBA), ELISA Assay, RIPA Assay |
Primary outcome
Comparsion of the specificity, sensitivity and clinical correlation
Time frame: 24 months
Comparsion the specificity,sensitivity and clinical correlation of CBA, RIPA and ELISA assay in autoantibodies detection of myasthenia gravis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 37554174Li Z, Zhang C, Chang T, Zhang X, Yang H, Gao F, Feng J, Liu H, Chen S, Wang L, Yang C, Li H, Pan Y, Palace J, Shi FD; SCREAM Study Investigators. A multicentre, prospective, double-blind study comparing the accuracy of autoantibody diagnostic assays in myasthenia gravis: the SCREAM study. Lancet Reg Health West Pac. 2023 Jul 19;38:100846. doi: 10.1016/j.lanwpc.2023.100846. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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.
Fu-Dong Shi, MD, Ph.D study chair
Beijing Tiantan Hospital,Tianjin Medical University General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detection Autoantibody of Myasthenia Gravis, run by Tianjin Medical University General Hospital at 2 sites 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: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparsion of the specificity, sensitivity and clinical correlation (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219097, which also lists 1 linked publication.
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 19 Jan 2023.