UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001580 |
|---|---|
| Receipt number | R000001836 |
| Scientific Title | GENOMIC DISEASE OUTCOME CONSORTIUM |
| Date of disclosure of the study information | 2008/12/16 |
| Last modified on | 2019/11/22 15:22:05 |
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Basic information
Public title
GENOMIC DISEASE OUTCOME CONSORTIUM
Acronym
G-DOC
Scientific Title
GENOMIC DISEASE OUTCOME CONSORTIUM
Scientific Title:Acronym
G-DOC
Region
| Japan |
Condition
Condition
metabolic syndrome
hypertension
chronic kidney disease
dyslipidemia
diabetes mellitus
obesity
preeclampsia
hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluation of difference of othe nset age of hard end points (renal death, acute myocardial infarction, stroke, admission for congestive heart failure, death) based on genotypes
Basic objectives2
Others
Basic objectives -Others
Cohort study based on genotypes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
renal death
acute myocardial infarction
admission for congestive heart failure
stroke
lower limb amputation
death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hypertension
diabetes mellitus
dyslipidemia
metabolic syndrome
chronic renal disease
Key exclusion criteria
scute phase disorder
severe organ failure
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Konoshita |
Organization
Fukui University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, 910-1193, Japan
TEL
0776-61-8353
konosita@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Konoshita |
Organization
Fukui University School of Medicine
Division name
Third Department of Internal Medicine
Zip code
910-1193
Address
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, 910-1193, Japan
TEL
0776-61-8353
Homepage URL
konosita@u-fukui.ac.jp
Sponsor or person
Institute
GENOMIC DISEASE OUTCOME CONSORTIUM (G-DOC) STUDY INVESTIGATORS
Institute
Department
Personal name
Funding Source
Organization
Fukui University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui University Hospital Medical Research Support Center
Address
23-3, Matsuokashimoaizuki, Eiheiji, Fukui, 910-1193, Japan
Tel
0776-61-8529
chiken@ml.u-fukui.ac.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
福井大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2001 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2001 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2001 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Obsevational assessment of onset of renal death, myocardial infarction, admission for congestive heart failure, stroke and death
Management information
Registered date
| 2008 | Year | 12 | Month | 16 | Day |
Last modified on
| 2019 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001836
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
