UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030722 |
|---|---|
| Receipt number | R000035075 |
| Scientific Title | Prenatal diagnosis of Duchenne muscular dystrophy |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2024/07/14 16:16:19 |
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Basic information
Public title
Prenatal diagnosis of Duchenne muscular dystrophy
Acronym
Prenatal diagnosis of Duchenne muscular dystrophy
Scientific Title
Prenatal diagnosis of Duchenne muscular dystrophy
Scientific Title:Acronym
Prenatal diagnosis of Duchenne muscular dystrophy
Region
| Japan |
Condition
Condition
Duchenne muscular dystrophy
Classification by specialty
| Neurology | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Prenatal diagnosis and genetic counseling for pregnant female diagnosed as a Duchenne muscular dystrophy carrier
Basic objectives2
Others
Basic objectives -Others
prenatal diagnosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The samples are collected from chorionic villi between 11 and 12 weeks of gastation or amnionic cells between 15 and 16 weeks of gestation.
If the fetus is male,The genetic testing is perfoemed.
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
The carrier can choose an examination for amniocentetis or chorionic villi sampling.
The amuniocentetis is performed between 15and 16 weeks of gestation and the chorionic villi is collected between 11 and 12 weeks of gestation.The samples are subjected to genetic testing in the division of Functional Genomics, Research Center for Bioscience and Technology, Tottori University.
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
pregnant female diagnosed DMD carrier
Key exclusion criteria
pregnant female who does not have a diagnosis of DMD carrier
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuuko Yokohama |
Organization
Asahikawa medical university
Division name
Division of obstetrics and Gynecology
Zip code
Address
Midrigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2562
yukoy@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuuko Yokohama |
Organization
Asahikawa medical university
Division name
Division of obstetrics and Gynecology
Zip code
Address
Midrigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan
TEL
0166-68-2562
Homepage URL
yukoy@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
Funding Source
Organization
payment of the patient
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
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
| 2018 | Year | 02 | 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
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 08 | Day |
Last modified on
| 2024 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035075
