UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045568 |
|---|---|
| Receipt number | R000052018 |
| Scientific Title | Database Research of Muscular Dystrophy Wards in Japan |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2023/02/14 07:11:08 |
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Basic information
Public title
Database Research of Muscular Dystrophy Wards in Japan
Acronym
Database Research of Muscular Dystrophy Wards in Japan
Scientific Title
Database Research of Muscular Dystrophy Wards in Japan
Scientific Title:Acronym
Database Research of Muscular Dystrophy Wards in Japan
Region
| Japan |
Condition
Condition
muscular dystrophy and other neuromuscular diseases
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Provides information necessary to promote neuromuscular disease policy medical care in the area of muscular dystrophy,
Basic objectives2
Others
Basic objectives -Others
By collecting data for research on basic pathological conditions such as motor dysfunction and respiratory disability and death, scientific information essential for establishing standard treatment and care can be obtained.
Establish a research source to promote joint clinical research targeting patients among neuromuscular disease policy medical network facilities.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Living patient
Layer 1: Attribute factor
Registration date, facility number, research subject identification code, consent acquisition date, date of birth (age), gender
Layer 2: Items that need continuous investigation
Input date, prefecture of origin, hospitalization date, contract hospitalization, hospitalization ward ID, height, weight
Diagnosis, diagnosis basis, motor function, respiratory status, time of introduction of artificial ventilation therapy, tracheostomy, nutritional management, heart failure treatment
Layer 3: Items to be investigated for a limited period depending on the project
Dead patient: date of death, cause of death, presence or absence of autopsy
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
Inpatients in the muscular dystrophy ward
Key exclusion criteria
Non-inpatients in the muscular dystrophy ward
Target sample size
2200
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
Division of Child Neurology, Department of Neurology
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
Division of Child Neurology, Department of Neurology
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
National Hospital Organization Muscular Dystrophy Facility Directors Meeting
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka
Tel
06-6853-2001
saito.toshio.cq@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
独立行政法人国立病院機構旭川医療センター(北海道)，北海道医療センター(北海道)，青森病院(青森県)，あきた病院(秋田県)，仙台西多賀病院(宮城県)，東埼玉病院(埼玉県)，下志津病院(千葉県)，箱根病院(神奈川県)，新潟病院(新潟県)，医王病院(石川県)，長良医療センター(岐阜県)，鈴鹿病院(三重県)，宇多野病院(京都府)，兵庫中央病院(兵庫県)，奈良医療センター(奈良県)，広島西医療センター(広島県)，松江医療センター（島根県），徳島病院（徳島県），大牟田病院（福岡県），熊本再春医療センター（熊本県），長崎川棚医療センター（長崎県），西別府病院（大分県），宮崎東病院（宮崎県），南九州病院（鹿児島県），沖縄病院（沖縄県）（予定含む）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 27 | 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
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Living patient
Layer 1: Attribute factor
Registration date, facility number, research subject identification code, consent acquisition date, date of birth (age), gender
Layer 2: Items that need continuous investigation
Input date, prefecture of origin, hospitalization date, contract hospitalization, hospitalization ward ID, height, weight
Diagnosis, diagnosis basis, motor function, respiratory status, time of introduction of artificial ventilation therapy, tracheostomy, nutritional management, heart failure treatment
Layer 3: Items to be investigated for a limited period depending on the project
Dead patient: date of death, cause of death, presence or absence of autopsy
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052018
