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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030185
Receipt No. R000034470
Scientific Title A clinical cohort study validating application of genetic information for health on cohort group.
Date of disclosure of the study information 2018/03/17
Last modified on 2017/11/30

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Basic information
Public title A clinical cohort study validating application of genetic information for health on cohort group.
Acronym Genetic information cohort study
Scientific Title A clinical cohort study validating application of genetic information for health on cohort group.
Scientific Title:Acronym Genetic information cohort study
Region
Japan

Condition
Condition Common diseases categorized under non-communicative disorders
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Ophthalmology Oto-rhino-laryngology Urology
Neurosurgery Cardiovascular surgery Laboratory medicine
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To establish a prospective study program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Running this program with having a high content from the participants.
Key secondary outcomes Establishment of a prospective cohort study system.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Gene Behavior,custom
Interventions/Control_1 Genetic information with doctor interview.
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
95 years-old >
Gender Male and Female
Key inclusion criteria Those who can visit Tokyo Medical and Dental University.
Key exclusion criteria 1) Those who have severe disease conditions.
2) Those who misunderstand this program, judged by pretest offered in the explanation sheet.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kinya Ishikawa
Organization Tokyo Medical and Dental University
Division name The Center for Personalized Medicine for Healthy Aging
Zip code
Address Bunkyo-ku, Yushima 1-5-45
TEL 0358034194
Email app.pmha@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aika Kuroda
Organization Tokyo Medical and Dental University
Division name The Center for Personalized Medicine for Healthy Aging
Zip code
Address Bunkyo-ku, Yushima 1-5-45
TEL 0358034194
Homepage URL
Email app.pmha@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2024 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034470

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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