UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041017 |
|---|---|
| Receipt number | R000046841 |
| Scientific Title | Epidemiological study on natural history of SMON patients |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2023/07/10 19:23:43 |
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Basic information
Public title
Epidemiological study on natural history of SMON patients
Acronym
Epidemiologic study of SMON patients
Scientific Title
Epidemiological study on natural history of SMON patients
Scientific Title:Acronym
Epidemiologic study of SMON patients
Region
| Japan |
Condition
Condition
SMON(subacute myelo-optico-neuropathy)
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, for the permanent measures of SMON patients, through the medical treatment of patients, we will figure out the current situation of SMON patients and support their medical treatment, and clarify their natural history.
Basic objectives2
Others
Basic objectives -Others
Conducting symptomatic treatment, longitudinally examining prognosis, searching for treatment methods, and enlightening activities.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SMON patients living in Gunma prefecture are treated regularly every year and their natural history is investigated. The contents of the survey will be entered into the "Smon Situation Survey Individuals' Form", which is unified throughout the country, and will be mailed to the "Smon Survey Research Group" secretariat for analysis nationwide.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Out-of-hospital survey
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
Patients living in Gunma prefecture and diagnosed as SMON
Key exclusion criteria
Patients who have not been diagnosed with SMON
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Ikeda |
Organization
Gunma university graduate school of medicine
Division name
Neurology
Zip code
371-8511
Address
showa 3-39-22, maebashi, Gunma, Japan
TEL
0272208061
ikeday006@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Kasahara |
Organization
Gunma university hospital
Division name
Neurology
Zip code
371-8511
Address
showa 3-39-15, maebashi, Gunma, Japan
TEL
0272208061
Homepage URL
kasahara2983ya@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Suzuka National Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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 Ethical Committee at Gunma University Hospital
Address
showa 3-39-15, maebashi, Gunma, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2020 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046841
| Research Plan | |
|---|---|
| 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 |
