UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026981 |
|---|---|
| Receipt number | R000028515 |
| Scientific Title | Prospective study of pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology by medical questionnaire |
| Date of disclosure of the study information | 2017/04/13 |
| Last modified on | 2018/08/12 11:20:24 |
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Basic information
Public title
Prospective study of pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology by medical questionnaire
Acronym
Prospective study of childhood diseases of allergy and immunology by questionnaire
Scientific Title
Prospective study of pathology, therapeutic effect and prognosis of childhood diseases of allergy and immunology by medical questionnaire
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Miwa Shinohara |
Organization
Ehime University Hospital
Division name
Department of Pediatrics
Zip code
Address
454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL
089-960-5320
shinohara.miwa.vv@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miwa Shinohara |
Organization
Ehime University Hospital
Division name
Department of Pediatrics
Zip code
Address
454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL
089-960-5320
Homepage URL
shinohara.miwa.vv@ehime-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Ehime University Hospital
Institute
Department
Personal name
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)
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
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 |
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028515
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
