UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027834 |
|---|---|
| Receipt number | R000031889 |
| Scientific Title | Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA |
| Date of disclosure of the study information | 2017/06/20 |
| Last modified on | 2024/12/25 17:08:34 |
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Basic information
Public title
Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA
Acronym
Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema
Scientific Title
Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA
Scientific Title:Acronym
Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema
Region
| Japan | North America | Australia |
Condition
Condition
Eczema
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
| Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In a high-risk birth cohort in pregnant mothers with eczema, we clarify transgenereationalmechanisum of fetal tobacco smoke exposure effects on the development of eczema using hair-related microRNA (miRNA).
Basic objectives2
Others
Basic objectives -Others
Using hair-related miRNA as a biomarker for the development of eczema.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploration of transgenerational hair-related miRNA
Key secondary outcomes
kinds of hair-related miRNA
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*Pregnant women (>= 28 gestation weeks)
*Pregnant mother and father with allergic diseases
*Pregnant mother and father without allergic diseases
Key exclusion criteria
*Pregnant mother with using medication
*Pregnant mother and father with chronic diseases, expect allergic diseases
*Pregnant mother who do not want avoid smoking
*Infants who born by cesarean section
*Premature infants
*Infants with with chronic diseases, expect allergic diseases
*Invidivuals with using supplements including vitamine
*Individuales with judgement of ineligible by a responsible researcher
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Shinohara |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-0033
Address
Department of Pediatrics
TEL
03-3813-3111
mi-shinohara@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Shinohara |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-0033
Address
3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN
TEL
03-3813-3111
Homepage URL
mi-shinohara@juntendo.ac.jp
Sponsor or person
Institute
Departments of Pediatrics
Juntendo University, Faculty of Medicine
3-1-3 Hongo, Bunkyo-ku
TOKYO, 113-0033, JAPAN
TEL +81-3-3813-3111
FAX +81-3-5800-1580
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Kojimachi Business Center Building,
5-3-1 Kojimachi, Chiyoda-ku,
Tokyo 102-0083
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo; Dr. Kenji Matsumoto
The University of Western Australia, Faculty of Health and Medical Sciences, Perth Children's Hospital, Telethon Kids Institute, Australia; Professor. Susan Prescott
Perth Children's Hospital, Telethon Kids Institute. Research psychologist with the ORIGINS Project, Australia; Dr. Lisa Gibson
Department of Allergy, Tokyo Metropolitan Children's Medical Center, Tokyo; Dr. Masami Narita
Department of Epidemiology and Preventive Medicine, Graduate School of Medicine, Ehime University, Ehime; Dr. Keiko Tanaka
Okayama Saiseikai General Hospital Department of Pediatrics, Section Head, Dr. Testuro Kitamura
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Departments of Pediatrics Juntendo University, Faculty of Medicine
Address
3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN
Tel
03-3813-3111
mi-shinohara@juntendo.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
順天堂大学医学部 小児科学講座
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
http://allergyimmunology.sx3.jp/
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
| Delay expected |
Results Delay Reason
Due to delays by the COVID-19 pandemic in establishing basic experiments and recruiting participants.
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Open the entry HP
Hair MiRNA KAKEN HP
http://allergyimmunology.sx3.jp/
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031889
