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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034619
Receipt No. R000039051
Scientific Title Investigation on effects of brain structures on non-neurological diseases
Date of disclosure of the study information 2018/10/31
Last modified on 2019/04/25

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Basic information
Public title Investigation on effects of brain structures on non-neurological diseases
Acronym Investigation on effects of brain structures on non-neurological diseases
Scientific Title Investigation on effects of brain structures on non-neurological diseases
Scientific Title:Acronym Investigation on effects of brain structures on non-neurological diseases
Region
Japan

Condition
Condition Common disease, Cancer, Autoimmune disease
Classification by specialty
Medicine in general Surgery in general Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Neurobiological investigations on effects of brains on non-neurological diseases.
Basic objectives2 Others
Basic objectives -Others Exploratory investigations on brain-body relationships.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Anatomical features of brains that had significant effects on the occurrence risk and prognosis of non-neurological diseases.
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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Individuals who underwent medical examinations in the hospitals in this project, accepted the possibility that their data would be used in academic researches after anonymisation, and did not claim any objections during the opt-out period for this project.
Key exclusion criteria Individuals with clear and explicit deficits, diseases, and lesions in their brains.
Target sample size 50000

Research contact person
Name of lead principal investigator
1st name Takamitsu
Middle name
Last name Watanabe
Organization RIKEN
Division name Centre for Brain Science
Zip code 351-0198
Address 2-1 Hirosawa Wako, Saitama, Japan
TEL 048-467-7126
Email takamitsu.watanabe@riken.jp

Public contact
Name of contact person
1st name Takamitsu
Middle name
Last name Watanabe
Organization RIKEN
Division name Centre for Brain Science
Zip code 351-0198
Address 2-1 Hirosawa Wako, Saitama, Japan
TEL 048-467-7126
Homepage URL
Email takamitsu.watanabe@riken.jp

Sponsor
Institute RIKEN Centre for Brain Science
Institute
Department

Funding Source
Organization RIKEN
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The University of Tokyo, Kamada Hospital, NTT Medical Centre
Name of secondary funder(s) JSPS

IRB Contact (For public release)
Organization RIKEN
Address 2-1 Hirosawa Wako Saitama, Japan
Tel 048-462-1111
Email human@riken.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2018018NI
Org. issuing International ID_1 The University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部附属病院(東京都)、亀田総合病院幕張クリニック(千葉県)、NTT関東病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2018 Year 10 Month 24 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039051

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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