UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050389 |
|---|---|
| Receipt number | R000057375 |
| Scientific Title | Preimplantation genetic testing for monogenic disease (neonatal infammatory skin and bowel disease 1) |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/02/20 17:00:24 |
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Basic information
Public title
Preimplantation genetic testing for monogenic disease (neonatal infammatory skin and bowel disease 1)
Acronym
Preimplantation genetic testing for monogenic disease (neonatal infammatory skin and bowel disease 1)
Scientific Title
Preimplantation genetic testing for monogenic disease (neonatal infammatory skin and bowel disease 1)
Scientific Title:Acronym
Preimplantation genetic testing for monogenic disease (neonatal infammatory skin and bowel disease 1)
Region
| Japan |
Condition
Condition
neonatal infammatory skin and bowel disease 1
Classification by specialty
| Gastroenterology | Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Not to deliver affected fetus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
delivery of a baby without neonatal infammatory skin and bowel disease 1
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
trophectoderm biopsy, DNA extraction, whole genome amplification and genetic testing for ADAM17 gene
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
compound heterozygous of ADAM17 missense
Key exclusion criteria
none
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Iwasa |
Organization
tokushima university hospital
Division name
Obstetrics and Gynecology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
+81-88-633-7177
yamamoto.yuri@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Yamamoto |
Organization
tokushima university hospital
Division name
Obstetrics and Gynecology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
+81886337177
Homepage URL
yamamoto.yuri@tokushima-u.ac.jp
Sponsor or person
Institute
tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
tokushima university hospital
Address
3-18-15 Kuramoto-cho, Tokushima
Tel
+81886337177
yamamoto.yuri@tokushima-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | 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
1
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057375
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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