UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041549 |
|---|---|
| Receipt number | 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 | 2023/02/27 12:11:13 |
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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 2021
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, Nakastu hospital, Tokushima university hospital, Kagoshima city hospital, Kirishima Medical center, Aozora clinic from April 2014 to December 2021
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
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
y.shingo.mie@gmail.com
Sponsor or person
Institute
Institute for Clinical Research, Mie National Hospital
Institute
Department
Personal name
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
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
Lack of data made it difficult for AI to predict OFC results with high accuracy.
Number of participants that the trial has enrolled
608
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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 25 | Day |
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
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.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 |
