UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003873 |
|---|---|
| Receipt number | R000004610 |
| Scientific Title | Prenatal diagnosis of Duchenne muscular dystrophy with duplication mutations in the dystrophin gene |
| Date of disclosure of the study information | 2010/08/01 |
| Last modified on | 2015/01/07 17:41:30 |
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Basic information
Public title
Prenatal diagnosis of Duchenne muscular dystrophy with duplication mutations in the dystrophin gene
Acronym
Prenatal diagnosis of Duchenne muscular dystrophy with duplication mutations
Scientific Title
Prenatal diagnosis of Duchenne muscular dystrophy with duplication mutations in the dystrophin gene
Scientific Title:Acronym
Prenatal diagnosis of Duchenne muscular dystrophy with duplication mutations
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
prenatal genetic diagnosis for DMD patient with duplication mutations
Basic objectives2
Others
Basic objectives -Others
prenatal genetic diagnosis of fetus whose family member(s) is (are) DMD patient(s) caused by duplication mutations in the dystrophin gene
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysis of the Y chromosome specific sequence, and polymorphisms in the dystrophin gene
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
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
prenatal diagnosis of fetal genomic DNA extracted from villi or amniotic fluid
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
Female
Key inclusion criteria
gravida whose family member(s) is(are) DMD patient(s) caused by duplication mutations in the dystrophin gene
Key exclusion criteria
turn the gestational age of 17 weeks,
impossible to do gene analysis of the family member(s) of the proband
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuo Masafumi |
Organization
Kobe University Graduate School of Medicine
Division name
Pediatrics
Zip code
Address
7-5-1,Kusunokicho, Chuo, Kobe, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Pediatrics
Zip code
Address
7-5-1,Kusunokicho, Chuo, Kobe
TEL
Homepage URL
Sponsor or person
Institute
Department of Pediatrics, Kobe University Graduate School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 05 | Day |
Last modified on
| 2015 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004610
| 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 |
