UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030185 |
|---|---|
| Receipt number | 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 11:52:19 |
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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
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
app.pmha@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
