UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054387 |
|---|---|
| Receipt number | R000062124 |
| Scientific Title | Evidence-generating research to clarify the current status and establish treatments for autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A) |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/11/14 12:59:11 |
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Basic information
Public title
Registry study of autoimmune glial fibrillary acidic protein (GFAP) astrocytopathy
Acronym
Registry study of GFAP-A
Scientific Title
Evidence-generating research to clarify the current status and establish treatments for autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A)
Scientific Title:Acronym
Evidence-generating research to clarify the current status and establish treatments for GFAP-A
Region
| Japan |
Condition
Condition
autoimmune glial fibrillary acidic protein (GFAP) astrocytopathy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
By accumulating clinical information on patients with autoimmune GFAP astrocytopathy and analyze thier clinical informations during long-term period, we will elucidate the natural history and prognostic factors of autoimmune GFAP astrocytopathy, and contribute to the development and establishment of new treatments for autoimmune GFAP astrocytopathy in the future.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) presence or absence of death
2) Clinical Assessment Scale in Autoimmune Encephalitis (CASE)
3) outcomes of modified Rankin Scale (mRS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Autoimmune GFAP astrocytopathy (GFAP-A) patients with anti-GFAP antibodies in cerebrospinal fluide detected by cell-based and tissue-based assays
2) GFAP-A patients with written informed consent to participate in the study
Key exclusion criteria
GFAP-A patients who are judged to be inappropriate as included subjects by researcher, etc.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Kimura |
Organization
Gifu University Graduate School of medecine
Division name
Department of Neurology
Zip code
501-1194
Address
Yanagido 1-1, Gifu City, Gifu, Japan
TEL
0582306253
kimura.akio.k8@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Kimura |
Organization
Gifu University Graduate School of Medecine
Division name
Department of Neurology
Zip code
501-1194
Address
Yanagido 1-1, Gifu City, Gifu, Japan
TEL
0582306253
Homepage URL
kimura.akio.k8@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medecine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency Medical Reserch and Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medecine, Ethics Committie
Address
Yoshida Konoe town, Sakyo-ku, kyoto city, Kyoto, Japan
Tel
0757534680
ethcom@kuhp.kyoto-u.ac.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
| 2024 | Year | 07 | Month | 01 | 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
Patient registration using the Electronic Data Capture (EDC) system commenced on May 1, 2025.
Results date posted
| 2025 | Year | 05 | Month | 15 | Day |
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2044 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data and biological samples (blood and cerebrospinal fluid) for biorepository and genomic analysis will be collected at the time of initial enrollment in patients with autoimmune GFAP astrocytopathy, and clinical data and blood samples from registered patients will be collected every 1 year.
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062124
