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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003873
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Pediatrics, Kobe University Graduate School of Medicine,
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004610

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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