UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032049 |
|---|---|
| Receipt number | R000036564 |
| Scientific Title | Frequency of gene variants with familial hypercholesterolemia in the large biobank-based population cohort |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/04/03 18:01:09 |
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Basic information
Public title
Frequency of gene variants with familial hypercholesterolemia in the large biobank-based population cohort
Acronym
Frequency of gene variants with familial hypercholesterolemia
Scientific Title
Frequency of gene variants with familial hypercholesterolemia in the large biobank-based population cohort
Scientific Title:Acronym
Frequency of gene variants with familial hypercholesterolemia
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the frequency of gene variants with familial hypercholesterolemia using the large biobank-based population cohort.
Basic objectives2
Others
Basic objectives -Others
Investigation of the frequency of gene variants with familial hypercholesterolemia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of gene variants with familial hypercholesterolemia
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
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adults living in Miyagi and Iwate prefecture
Key exclusion criteria
N/A
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawame |
Organization
Tohoku University
Division name
Tohoku Medical Megabank Organization
Zip code
980
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi
TEL
022-274-6017
hkawame@megabank.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | Sawada |
Organization
Tohoku University
Division name
Hospital
Zip code
980
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
TEL
022-717-7611
Homepage URL
ssawada@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
Tel
+81227177611
ssawada@med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | 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
3000
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 | 02 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036564
