UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045633 |
|---|---|
| Receipt number | R000052094 |
| Scientific Title | Research on newborn screening for treatable neonatal and childhood diseases |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/04/01 10:02:46 |
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Basic information
Public title
Research on newborn screening for treatable neonatal and childhood diseases
Acronym
Research on expanded newborn screening
Scientific Title
Research on newborn screening for treatable neonatal and childhood diseases
Scientific Title:Acronym
Research on expanded newborn screening
Region
| Japan |
Condition
Condition
primary immunodeficiency, spinal muscular atrophy
Classification by specialty
| Obstetrics and Gynecology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim for early diagnosis and treatment by performing newborn screening for primary immunodeficiency and spinal muscular atrophy using dried blood spots.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
establishment of implementation system (1 year from the start)
Key secondary outcomes
evaluation of efficacy (epidemiological survey in 10 years)
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
| Other |
Interventions/Control_1
screening for primary immunodeficiency and spinal muscular atrophy
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
| 1 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
newborns undergoing current newborn screening
Key exclusion criteria
consent not available
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Kohsuke |
| Middle name | |
| Last name | Imai |
Organization
Tokyo Medical and Dental University
Division name
Pediatrics
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo, Tokyo
TEL
0338136111
kimai.ped@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Mizuno |
Organization
Tokyo Medical and Dental University
Division name
Pediatrics
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo, Tokyo
TEL
0338136111
Homepage URL
tmizuno.ped@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The department of general affairs, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2022 | Year | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2032 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052094
