UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048900 |
|---|---|
| Receipt number | R000055083 |
| Scientific Title | Establishment of expanded newborn screening system in Tokyo metropolitan |
| Date of disclosure of the study information | 2022/09/09 |
| Last modified on | 2022/09/09 18:48:11 |
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Basic information
Public title
Establishment of expanded newborn screening system in Tokyo metropolitan
Acronym
Establishment of expanded newborn screening system in Tokyo metropolitan
Scientific Title
Establishment of expanded newborn screening system in Tokyo metropolitan
Scientific Title:Acronym
Establishment of expanded newborn screening system in Tokyo metropolitan
Region
| Japan |
Condition
Condition
Spiral Muscular Atrophy, Severe Combinede Immunodeficiency, Pompe Disease, Mucopolysaccharidosis type I & II, Fabry disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Establishment of expanded newborn screening system in Tokyo metropolitan (target disease: spiral muscular atrophy, severe combinded immunodeficiency, Pompe disease, mucopolysaccharidosis type I & II and Fabry disease)
Basic objectives2
Others
Basic objectives -Others
A pillot study of expanded newborn screening conducted for newborns born at Jikei university hospital and Gonohashi obstetrics and gynecology hospital
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of target disease
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
| Other |
Interventions/Control_1
Expanded newborn screening
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
| 4 | days-old | <= |
Age-upper limit
| 28 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Newborns born at Jikei University Hospital and Gonohashi Obstetrics and Gynecology Hospital with the consent of their parents
Key exclusion criteria
Newborns who died within day 3
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Masahisa |
| Middle name | |
| Last name | Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Pediatrics
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL
03-3433-1111
masa-koba@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Masahisa |
| Middle name | |
| Last name | Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Pediatrics
Zip code
105-8461
Address
3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
masa-koba@jikei.ac.jp
Sponsor or person
Institute
Department of Pediatrics, The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Health Service Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8 Nishishinbashi Minato-ku, Tokyo
Tel
03-3333-1111
rinri@jikei.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 | 09 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 09 | Month | 09 | Day |
Last modified on
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055083
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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