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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041549
Receipt No. R000047438
Scientific Title AI system for egg OFC Prediction System of Infants
Date of disclosure of the study information 2020/08/31
Last modified on 2020/09/10

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Basic information
Public title AI system for egg OFC Prediction System of Infants
Acronym e-OPSI
Scientific Title AI system for egg OFC Prediction System of Infants
Scientific Title:Acronym e-OPSI
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 predicting outcomes of infant egg oral challenge test by artificial intelligence
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total dose of oral food challenge test
Anaphylaxis Scoring Aichi: ASCA
prediction of positive rate by dose
Key secondary outcomes prediction of intakes 1-3 months and 6-12 months after oral challenge test

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
4 months-old <=
Age-upper limit
12 months-old >
Gender Male and Female
Key inclusion criteria 1) For AI learning: Infants who underwent oral egg loading tests at Mie National Hospital, Tokuda family clinic, Kainuma internal medicine, Fujita medical university bantane hospital from April 2014 to December 2020
2) For predicting AI predictive ability: Infants who underwent oral egg loading tests atMie National Hospital, Tokuda family clinic, Kainuma internal medicine, Fujita medical university bantane hospital from April 2014 to December 2020
Key exclusion criteria 1) Those who have missing necessary items in clinical background
2) Those who wished to opt out of this research
3) When the principal investigator and co-investigators determine that participation in this research is not appropriate
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Yamada
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code 514-0125
Address 357 Ozato Kubota, Tsu city, Mie 514-0125, JAPAN
TEL 059-232-2531
Email y.shingo.mie@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Yamada
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code 514-0125
Address 357 Ozato Kubota, Tsu city, Mie 514-0125, JAPAN
TEL 059-232-2531
Homepage URL
Email y.shingo.mie@gmail.com

Sponsor
Institute Institute for Clinical Research, Mie National Hospital
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institute for Clinical Research, Mie National Hospital
Address 357 Ozato Kubota, Tsu city, Mie 514-0125, JAPAN
Tel 059-232-2531
Email y.shingo.mie@gmail.com

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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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
2020 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 31 Day
Last follow-up date
2023 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Collect the following information about the first oral challenge test (OFC) in infants with suspected egg allergy. Age, sex, history of breast milk usage, persistent eczema of infants or atopic dermatitis, history of wheezing, presence or absence of multi-antigen sensitization, presence or absence of induced symptoms (presence or absence of anaphylaxis), total IgE, Egg white/ovomucoid-specific IgE antibody, specific IgE for each item if there is a test history other than eggs, family history of allergies (father, mother, brother), parent's anxiety (fear of ingestion at home, kindergarten admission, etc), OFC total dose, positive rate, ASCA, OFC results, intake 1-3 months after OFC, intake 6-12 months.
The AI learn these clinical backgrounds, and the AI system will predict positive rate for each OFC total dose, ASCA, and intake situation after OFC.

Management information
Registered date
2020 Year 08 Month 25 Day
Last modified on
2020 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047438

Research Plan
Registered date File name
2020/09/04 人工知能による乳児鶏卵OFC予測_研究計画書_山田.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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