UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045475 |
|---|---|
| Receipt number | R000051915 |
| Scientific Title | Observational study for the immunopathogenesis in myasthenia gravis using peripheral blood and resected thymus tissue |
| Date of disclosure of the study information | 2021/09/14 |
| Last modified on | 2022/09/21 23:12:41 |
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Basic information
Public title
The study investigating the immuno-pathogenesis in myasthenia gravis using peripheral blood and resected thymus tissue
Acronym
The study investigating the pathogenesis of myasthenia gravis using peripheral blood and thymus tissue
Scientific Title
Observational study for the immunopathogenesis in myasthenia gravis using peripheral blood and resected thymus tissue
Scientific Title:Acronym
The study for investigating the pathogenesis of myasthenia gravis using peripheral blood and thymus tissue
Region
| Japan |
Condition
Condition
Myasthenia gravis
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the immunopathogenesis of myasthenia gravis by analysing differentiation or activation of immuno-related cells in peripheral blood, and thymocyte and stromal cells in thymus resected by thymectomy treatment
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of immuno-related cells from peripheral blood or thymus, Cytokine production pattern, Serum immuno-related protein levels such as cytokine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling for healthy control
Interventions/Control_2
Blood sampling for myasthenia gravis
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with myasthenia gravis, neuro-immunological disorders, non-inflammatory neurological disorders, who present in Chiba University Hospital. Healthy volunteers recruited from staffs of the hospital.
Key exclusion criteria
Those who disagree with the content of the study
For healthy volunteers, those who have some neurological disorders or medical diseases with potential neurological complication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwahara |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Neurology
Zip code
260-8670
Address
1-8-1, Inohana, Chuou-ku, Chiba city
TEL
043-226-2129
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kojima |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Neurology
Zip code
260-8670
Address
1-8-1, Inohana, Chuou-ku, Chiba city
TEL
043-226-2129
Homepage URL
ytkjm@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
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
the Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1, Inohana, Chuou-ku, Chiba city
Tel
043-226-2496
inohana-rinri@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 14 | 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
| 2021 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2022 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051915
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
