UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034619
Receipt number 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 2023/10/31 13:55:10

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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 or person

Institute

RIKEN Centre for Brain Science

Institute

Department

Personal name



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

https://www.todai-yobouigaku-dock.jp/contents/center/research.html

Publication of results

Unpublished


Result

URL related to results and publications

https://www.todai-yobouigaku-dock.jp/contents/center/research.html

Number of participants that the trial has enrolled

1000

Results

Under analysis. Not allowed to be publish publicly yet.

Results date posted

2023 Year 10 Month 31 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Adults who attended at the annual health check at several hospitals.

Participant flow

We utilised the data recorded from the patients who did not choose opt out of this trial.

Adverse events

NA

Outcome measures

Predictability

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

2023 Year 10 Month 31 Day



Link to view the page

Value
https://center6.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