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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041017
Receipt No. R000046841
Scientific Title Epidemiological study on natural history of SMON patients
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/06

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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
Email ikeday006@gunma-u.ac.jp

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Nagashima
Organization Gunma university hospital
Division name Neurology
Zip code 371-8511
Address showa 3-39-15, maebashi, Gunma, Japan
TEL 0272208061
Homepage URL
Email nagakazu@gunma-u.ac.jp

Sponsor
Institute National Hospital Organization Suzuka National Hospital
Institute
Department

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
Email 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
2021 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
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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