UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041135 |
|---|---|
| Receipt number | R000046974 |
| Scientific Title | Development of Artificial Intelligence (AI) to accelerate Drug Target discovery |
| Date of disclosure of the study information | 2020/07/17 |
| Last modified on | 2023/02/01 16:36:20 |
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Basic information
Public title
Development of Artificial Intelligence (AI) to accelerate Drug Target discovery
Acronym
Development of Artificial Intelligence (AI) to accelerate Drug Target discovery
Scientific Title
Development of Artificial Intelligence (AI) to accelerate Drug Target discovery
Scientific Title:Acronym
Development of Artificial Intelligence (AI) to accelerate Drug Target discovery
Region
| Japan |
Condition
Condition
Interstitial Lung Disease including IPF (Idiopathic Pulmonary Fibrosis)
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1) Construction of an integrated disease database for interstitial pneumonia (including IPF) and lung cancer.
2) Development of AI for the analysis of the integrated disease database.
3) Open platform construction/development.
Basic objectives2
Others
Basic objectives -Others
1) For IPF and Lung cancer, discover one or more factors that can be new drug targets or disease biomarkers for each disease.
2) Establish the schemes and methodologies for discovering drug targets and disease biomarkers from the patient records and molecular information, and generalize them to other diseases.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
There are no evaluation items such as primary outcomes for this observational research, which constructs a database and AI.
Key secondary outcomes
Same as above.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
*Interstitial pneumonia including IPF (including suspicion)
Those who meet the conditions (1)-(5):
(1) Patients with interstitial pneumonia including IPF (including suspicion) who visited the hospital between April 1, 2012 and March 31, 2025.
(2) Patients who can provide consent to participate in this study for themselves.
(3) Patients aged 16 years or older at the time of obtaining consent.
(4) For both male and female
(5) For both inpatient and outpatient
*Lung cancer
(1)Patients who have been diagnosed with lung cancer and have provided consent for surgery.
(2) No age limitation.
(3) No other specific criteria for inclusion.
Key exclusion criteria
*Interstitial pneumonia including IPF (including suspicion)
Patients who were judged to be unsuitable for participating in this study by the doctor in charge.
*Lung cancer
nothing special
Target sample size
3700
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Natsume |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Laboratory of Bioinformatics
Zip code
5670085
Address
7-6-8 Saito-Asagi, Ibaraki, Osaka, Japan
TEL
072-639-7010
natsume@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Yayoi |
| Middle name | |
| Last name | Natsume |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Laboratory of Bioinformatics
Zip code
5670085
Address
7-6-8 Saito-Asagi, Ibaraki, Osaka, Japan
TEL
072-639-7010
Homepage URL
natsume@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University
Kanagawa Cardiovascular and Respiratory Center
National Cancer Center
Tokushima University
Kyoto University
Nara Institute of Science and Technology
Ochanomizu University
Kyushu Institute of Technology
RIKEN
Karydo TherapeutiX, Inc.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito-Asagi, Ibaraki, Osaka, Japan
Tel
072-641-9829
irb-office@nibiohn.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
大阪大学（大阪府）、神奈川県立循環器呼吸器病センター（神奈川県）、国立がん研究センター（東京都）、徳島大学（徳島県）、京都大学（京都府）、奈良先端科学技術大学（奈良県）、お茶の水女子大学（東京都）、九州工業大学（福岡県）、理化学研究所（東京都）、Karydo TherapeutiX株式会社（東京都）、株式会社医学生物学研究所（東京都）
Osaka University(Osaka), Kanagawa Cardiovascular and Respiratory Center(Kanagawa), National Cancer Center(Tokyo), Tokushima University(Tokushima), Kyoto University(Kyoto), Nara Institute of Science and Technology(Nara), Ochanomizu University(Tokyo), Kyushu Institute of Technology(Fukuoka), RIKEN(Tokyo), Karydo TherapeutiX, Inc.(Tokyo), MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-institutional joint study/registry study
Prospective/retrospective (partially) study
Presence or absence of intervention: Absence
Presence or absence of randomized allocation: Absence
Existence of invasion: minor invasion.
Scale of study: Multi-institutional joint study.
Use of unapproved medical devices: None
Management information
Registered date
| 2020 | Year | 07 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046974
| Research Plan | |
|---|---|
| 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 |
