UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008960 |
|---|---|
| Receipt number | R000010508 |
| Scientific Title | Development of screener for the diagnosis of myotonic dystrophy |
| Date of disclosure of the study information | 2012/09/23 |
| Last modified on | 2014/09/23 11:24:56 |
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Basic information
Public title
Development of screener for the diagnosis of myotonic dystrophy
Acronym
Development of screener for the diagnosis of myotonic dystrophy
Scientific Title
Development of screener for the diagnosis of myotonic dystrophy
Scientific Title:Acronym
Development of screener for the diagnosis of myotonic dystrophy
Region
| Japan |
Condition
Condition
Myotonic dystrophy
Classification by specialty
| Medicine in general | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Myotonic dystrophy is a multi-systemic disease which many medical professionals may encounter in their daily practice. The aim of this study is to develop a simple screening tool for the diagnosis of myotonic dystrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability and applicability of screener
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ambulant outpatients with myotonic dystrophy and other disorders, and their accompanied family members.
Key exclusion criteria
Severe physical or mental impairment
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori P. Takahashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka JAPAN
TEL
06-6879-5111
mtakahas@neurol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori P. Takahashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka JAPAN
TEL
06-6879-5111
Homepage URL
mtakahas@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
National Hospital Organization Toneyama Hospital
National Hospital Organization Higashi-Saitama Hospital
Hyogo College of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学大学院医学系研究科（大阪府）
国立病院機構 刀根山病院（大阪府）
国立病院機構 東埼玉病院(埼玉県)
兵庫医科大学 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/ncn3.93/full
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 05 | Month | 06 | Day |
Other
Other related information
Neurological examination and questionnaire
Management information
Registered date
| 2012 | Year | 09 | Month | 22 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010508
