UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology by medical questionnaire
Title of the study (Brief title)	Prospective study of childhood diseases of allergy and immunology by questionnaire
Region	Japan

Condition
Condition	Childhood diseases of allergy and immunology
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the predictive and prognostic factors, we investigate the pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology with statistical analysis of the medical data of family history, environmental factors and others by questionnaire.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The predictive and prognostic factors of the questionnaire associated the pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology.
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	0 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	children with childhood diseases of allergy and immunology with written informed consent
Key exclusion criteria	children with childhood diseases of allergy and immunology without written informed consent
Target sample size	600

Research contact person
Name of lead principal investigator	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
Address	454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL	089-960-5320
Email	shinohara.miwa.vv@ehime-u.ac.jp

Public contact
Name of contact person	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
Address	454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL	089-960-5320
Homepage URL
Email	shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Ehime University Hospital
Institute
Department

Funding Source
Organization	Department of Pediatrics, Ehime University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development
Name of secondary funｄer(s)

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	愛媛大学医学部附属病院　小児科（愛媛）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 09 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Using self-writing questionnaires

Management information
Registered date	2017 Year 04 Month 13 Day
Last modified on	2018 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028515