UMIN-CTR Clinical Trial

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)
Email	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
Email	sugie-m@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022387