UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047407 |
|---|---|
| Receipt number | R000054011 |
| Scientific Title | Elucidation of the molecular pathogenesis of myasthenia gravis using single-cell RNA analysis. |
| Date of disclosure of the study information | 2022/04/05 |
| Last modified on | 2022/04/05 23:46:48 |
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Basic information
Public title
Elucidation of the molecular pathogenesis of myasthenia gravis using single-cell RNA analysis.
Acronym
Elucidation of the molecular pathogenesis of myasthenia gravis using single-cell RNA analysis.
Scientific Title
Elucidation of the molecular pathogenesis of myasthenia gravis using single-cell RNA analysis.
Scientific Title:Acronym
Elucidation of the molecular pathogenesis of myasthenia gravis using single-cell RNA analysis.
Region
| Japan |
Condition
Condition
Myasthenia gravis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective is to comprehensively analyze mRNA expression at the one-cell level in myasthenia gravis by single-cell RNA analysis, to clarify the molecular pathogenesis and diversity of myasthenia gravis, and to create a classification according to molecular dynamics.
Basic objectives2
Others
Basic objectives -Others
Clinical information on patients with myasthenia gravis and association of blood test results, such as acetylcholine receptor antibody titer, with comprehensive RNA expression and TCR/BCR repatoires obtained by single cell RNA sequence.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical Information for Patients with Myasthenia Gravis
Acetylcholine receptor antibody titer
Comprehensive RNA expression obtained by single cell RNA sequence
Association with TCR and BCR Repatoires
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acetylcholine receptor antibody positive
Patients with generalized myasthenia gravis
healthy volunteers
Key exclusion criteria
1) Patients with other autoimmune diseases
2) Patients with carried cancer
3) Persons who have expressed their refusal to participate in this study through a release of information document.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | KUwabara |
Organization
Chiba University Hospital
Division name
Department of Neurology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Akamine |
Organization
Chiba University Hospital
Division name
Department of Neurology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
caya3424@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba
Tel
043-222-7171
caya3424@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-treatment blood samples are used when diagnosing disease. Clinical information and blood collection items will be obtained within the scope of normal medical care.
For healthy subjects, blood samples will be drawn after obtaining consent.
Management information
Registered date
| 2022 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
