UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019359 |
|---|---|
| Receipt number | R000022387 |
| Scientific Title | Investigation of the bio-markers in infants predicting the onset of childhood asthma |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2022/10/26 21:16:22 |
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Basic information
Public title
Investigation of the bio-markers in infants predicting the onset of childhood asthma
Acronym
Investigation of the bio-markers predicting the onset of childhood asthma
Scientific Title
Investigation of the bio-markers in infants predicting the onset of childhood asthma
Scientific Title:Acronym
Investigation of the bio-markers predicting the onset of childhood asthma
Region
| Japan |
Condition
Condition
Childhood asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the bio-markers predicting the onset of childhood asthma
Basic objectives2
Others
Basic objectives -Others
Investigation of the bio-markers predicting the onset of childhood asthma
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Onset of childhood asthma
Key secondary outcomes
persistent wheeze at 5 or 6 years of age
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
| 0 | years-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients consulted the National Center for Child Health and Development or Tokai University Hospital
Key exclusion criteria
(1)Patients with repeated nose bleeding by pituita suction
(2)Patients receiving systemic corticosteroid treatment
(3)Patients with other difficulties judged by the attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Sugie |
Organization
National Center for Child Health and Development
Division name
Department of allergy and clinical immunology
Zip code
157-8535
Address
2-10-1 Okura Setagaya, Tokyo 157-8535
TEL
03-5494-7120(4970)
sugie-m@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Sugie |
Organization
National Center for Child Health and Development
Division name
Department of allergy and clinical immunology
Zip code
157-8535
Address
2-10-1 Okura Setagaya, Tokyo 157-8535
TEL
03-5494-7120(4970)
Homepage URL
sugie-m@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Pediatrics, Tokai University
Division of allergy, Department of medical subspecialties, National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura Setagaya, Tokyo 157-8535
Tel
03-3416-0181
rinri@ncchd.go.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
国立研究開発法人 国立成育医療研究センター (東京都)
(National Center for Child Health and Development)
東海大学医学部専門診療学系小児科学 （神奈川県）
(Department of Pediatrics, Tokai University)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 15 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 02 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 02 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 02 | Day |
Other
Other related information
Study design: prospective cohort study
Subject recruiting method: October 2015-Oct 2016
Patients consulted the National Center for Child Health and Development or Tokai University Hospital except for key exclusion criteria who fulfill inclusion criteria
(1)Age (at the blood sampling)
(2)Sex
(3)Family history: Allergic disease
(4)Medical history: (asthma, atopic dermatitis, allergic rhinitis, allergic conjunctivitis, food allergy )
(5)Serum specific IgE: within a year before/after the blood sampling (Dermatophagoides pteronyssinus, Japanease cedar, dog dander, cat danger, Alternaria )
(6)Total serum IgE
(7)Cytokine and chemokine concentration in the serum and nasal drip
(IL-33, sCD40L, VEGF, TNF-b,TNF-a, TGF-a, RANTES, PDGF-AB/BB, PDGF-AA, MIP-1b, MIP-1a MDC (CCL22), MCP-3, MCP-1, IP-10, IL-17A, IL-15, IL-13, IL-12 (p70), IL-12 (p40), IL-10, IL-9, IL-8, IL-7, IL-6, IL-5, IL-4, IL-3, IL-2, IL-1ra, IL-1b, IL-1a, IFN-g,IFN-a2, GRO, GM-CSF, G-CSF, Fractalkine, Flt-3 ligand, FGF-2, Eotaxin, EGF, GCP2, NAP2, MIP-3b, MIP-3a /CCL20, MIG, M-CSF, Lymphotactin, IL-29, IL-11, I-TAC, HCC-1, 6Ckine, TSLP, TRAIL, TPO, TARC, SDF-1A+b SCF, MIP-1d, MCP-4, MCP-2, LIF, IL-33, IL-28A, IL-23, IL-21, IL-20, IL-16, I-309, Eotaxin-3, Eotaxin-2, ENA-78, CTACK, BCA-1)
(8)Age at the onset of asthma: only patients with asthma
(9)Severity: only patients with asthma
(10)Peripheral eosinophil counts: within a year before/after the blood sampling
(11)Types of Viral infection
(12)Medical treatment receiving at the enrollment
(13)Inhaled corticosteroid use
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022387
| 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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