UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041696 |
|---|---|
| Receipt number | R000047595 |
| Scientific Title | Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center |
| Date of disclosure of the study information | 2020/09/07 |
| Last modified on | 2021/03/07 10:02:14 |
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Basic information
Public title
Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Acronym
Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Scientific Title
Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Scientific Title:Acronym
Construction of database and analysis of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Region
| Japan |
Condition
Condition
spinal muscular atrophy
Classification by specialty
| Neurology | Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct database of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Basic objectives2
Others
Basic objectives -Others
To analyze the information of database of clinical condition of spinal muscular atrophy in NHO Osaka Toneyama Medical Center
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
General condition, respiratory status, nutritional status, changes in motor function
Key secondary outcomes
changes in motor function by drug administration
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
patient diagnosed as spinal muscular atrophy
Key exclusion criteria
patient who is not diagnosed as spinal muscular atrophy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Neurology Department
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka
TEL
06-6853-2001
saito.toshio.cq@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Neurology Department
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka
TEL
06-6853-2001
Homepage URL
saito.toshio.cq@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Department of Clinical Research, National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka
Tel
06-6853-2001
410-chiken@mail.hosp.go.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 | 09 | Month | 07 | 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
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research object code, birth year and month, gender,Diagnostic basis, Motor milestone, etc.
Clinical information:
Height, body weight,
motor function (ambulant, wheel chair, bed ridden,etc)
Respiratory function (voluntary, non-invasive ventilation, invasive ventilation, time of introducing, etc)
Nutritional method (per oral, tube feeding, gastrostomy tube, time of introducing,etc)
Other complication (heart failure, etc)
Medication
Evaluation of rehabilitation:
Manual muscle test:MMT, Hammersmith Functional Motor Scale-Expanded:HFMSE for SMA, revised upper limb mudule: RULM, grip power, pinch power, 2-minute walk distance, 10-meter walking evaluation, VC,CPF,MIC, etc
Clinical laboratory test:
Blood analysis, blood chemistry, atrial blood gas analysis
Chest x-ray, spine x-ray, MRI(brain, muscle, etc), CT (brain, muscle, chest, etc), echocardiography, electrocardiography, respiratory function (FVC,%FVC, etc)
Management information
Registered date
| 2020 | Year | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047595
| 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 |
