UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051480 |
|---|---|
| Receipt number | R000058723 |
| Scientific Title | Exploratory Research on Digital Biomarkers in Neuroimmune Disorders |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/29 12:18:37 |
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Basic information
Public title
Exploratory Research on Digital Biomarkers in Neuroimmune Disorders
Acronym
Intervention Study with Data Extraction using Digital Devices
Scientific Title
Exploratory Research on Digital Biomarkers in Neuroimmune Disorders
Scientific Title:Acronym
Intervention Study with Data Extraction using Digital Devices
Region
| Japan |
Condition
Condition
Neurological disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying factors related to the quality of life (QoL) of patients with neuroimmune disorders through digital biomarkers obtained via smartphones and other digital devices (IoT).
Basic objectives2
Others
Basic objectives -Others
Exploratory research on digital biomarkers (prospective, cross-sectional)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exploratory research on the correlation between electronic Patient-Reported Outcomes (ePRO) and Personal Health Records (PHR) with background information, disease information, physical examination findings, and test results.
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
| 16 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study focuses on patients with multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), and myasthenia gravis (MG) who have the capacity for autonomous decision-making during their hospital visits. For patients under the age of 18 with decision-making capacity, their participation will be subject to obtaining consent from their parents. Healthy volunteers for comparison will be individuals who have provided informed consent to participate in the study.
The diagnostic criteria and inclusion criteria for each disease are as follows:
MS: Patients diagnosed according to the 2017 McDonald diagnostic criteria for MS.
NMOSD: Patients diagnosed with NMOSD and tested positive for anti-aquaporin-4 antibodies, in accordance with the 2015 international diagnostic criteria for NMOSD.
MG: Patients diagnosed with myasthenia gravis based on the 2022 Guidelines for the Treatment of Myasthenia Gravis, either with positive anti-acetylcholine receptor antibodies or positive MuSK antibodies.
Key exclusion criteria
Patients under 15 years of age
Patients whose attending physician determines that participation in this study is inappropriate
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kenzo |
| Middle name | |
| Last name | Sakurai |
Organization
St. Marianna University School of Medicine
Division name
Department of Neurology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
+81449778111
k2sakurai@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Sakurai |
Organization
St. Marianna University School of Medicine
Division name
Department of Neurology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa, Japan
TEL
+81449778111
Homepage URL
k2sakurai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine, Ethics Committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2023 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058723
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
