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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041135
Receipt No. 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 2020/07/17

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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, 2022.
(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 4700

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Mizuguchi
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 072-641-9890
Email kenji@nibiohn.go.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Mizuguchi
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 072-641-9890
Homepage URL
Email kenji@nibiohn.go.jp

Sponsor
Institute National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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
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
Email 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)

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)

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
2022 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
2020 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046974

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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