UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047985 |
|---|---|
| Receipt number | R000054703 |
| Scientific Title | Exploratory data base study: developing multivariable prediction model for malnutrition prognosis or diagnosis using electronic medical record data and AI |
| Date of disclosure of the study information | 2022/06/08 |
| Last modified on | 2022/06/08 11:34:15 |
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Basic information
Public title
Solving problems to realize new clinical nutrition management based on medical information using ICT
Acronym
Solving problems to realize new clinical nutrition management based on medical information using ICT
Scientific Title
Exploratory data base study: developing multivariable prediction model for malnutrition prognosis or diagnosis using electronic medical record data and AI
Scientific Title:Acronym
Exploratory data base study: developing multivariable prediction model for malnutrition prognosis or diagnosis using electronic medical record data and AI
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
develop multivariable prediction model for malnutrition prognosis or diagnosis using electronic medical record data and AI
Basic objectives2
Others
Basic objectives -Others
Observational
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Malnutrition
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Inpatients who were hospitalized and discharged between May 1, 2013 and September 30, 2018
2) Outpatients who visited between May 1, 2013 and September 30, 2018
Key exclusion criteria
-
Target sample size
190000
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Tsuchihara |
Organization
National Cancer Center
Division name
Exploratory Oncology Research & Clinical Trial Center Division of Translational Informatics
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
ktsuchih@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Tsuchihara |
Organization
National Cancer Center
Division name
Exploratory Oncology Research & Clinical Trial Center Division of Translational Informatics
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
ktsuchih@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Fujitsu Limited
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Fujitsu Limited
Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo ku, Tokyo, Japan
Tel
04-7133-1111
irst@ml.res.ncc.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 08 | 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
20000
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Utilize AI and the electronic medical record of National Cancer Center Hospital East to build a model for predicting malnutrition at early stage.
Management information
Registered date
| 2022 | Year | 06 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054703
