UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036079 |
|---|---|
| Receipt number | R000041100 |
| Scientific Title | Relationship between perinatal FOXP3 positive T cells and histone deacetylase |
| Date of disclosure of the study information | 2019/03/10 |
| Last modified on | 2019/03/04 17:36:29 |
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Basic information
Public title
Relationship between perinatal FOXP3 positive T cells and histone deacetylase
Acronym
Relationship between perinatal regulatory T cells and epigenetics
Scientific Title
Relationship between perinatal FOXP3 positive T cells and histone deacetylase
Scientific Title:Acronym
Relationship between perinatal regulatory T cells and epigenetics
Region
| Japan |
Condition
Condition
Allergy/Immunology
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify factors related to perinatal regulatory T cell expression
Basic objectives2
Others
Basic objectives -Others
Identify factors related to perinatal regulatory T cell expression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Find differences in HDAC inhibitory capacity between adults and umbilical cord blood
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | days-old | <= |
Age-upper limit
| 6 | days-old | > |
Gender
Male and Female
Key inclusion criteria
normal term infant
Key exclusion criteria
Exclusion criteria were preterm deliveries, multiple gestation (twins, triplets), perinatal infections including fever around birth, maternal intake of medication, and maternal chronic diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamazaki Susumu |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
3-1-3, Hongo,Bunkyo, Tokyo
TEL
0338133111
susumu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Yamazaki |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
3-1-3, Hongo,Bunkyo, Tokyo
TEL
0338133111
Homepage URL
susumu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
This work was supported by KAKENHI (Grants-in-Aid for Scientific Research from the Japanese Ministry of Education, Culture, Sports Science and Technology; 16K19667).
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JPN
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
順天堂大学附属順天堂静岡病院、順天堂大学順天堂医院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 10 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
After approval of the ethics committee, the ability to inhibit histone acetylation of umbilical cord blood serum of normal newborn was examined.
Management information
Registered date
| 2019 | Year | 03 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041100
