UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027868 |
|---|---|
| Receipt number | R000029083 |
| Scientific Title | Gene research for familial hypercholesterolemia using next-generation sequencing technology |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2020/06/24 10:18:51 |
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Basic information
Public title
Gene research for familial hypercholesterolemia using next-generation sequencing technology
Acronym
Gene research for familial hypercholesterolemia
Scientific Title
Gene research for familial hypercholesterolemia using next-generation sequencing technology
Scientific Title:Acronym
Gene research for familial hypercholesterolemia
Region
| Japan |
Condition
Condition
Familial hypercholesterolemia
Familial hypocholesterlemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study is to elucidate the mutation in the lipid metabolism gene among familial dyslipidemia patients using next-generation sequencing technique.
Basic objectives2
Others
Basic objectives -Others
To elucidate the new mutation in the lipid metabolism gene if well-known gene mutation is not detected.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of gene mutation in lipid metabolism gene among familial dyslipidemia patients
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Blood sampling for parents of diagnosed familial dyslipidemia patients
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are suspected for familial dyslipidemia and meet one of the below criteria.
1)LDL-C > 250 mg/dl
2)LDL-C < 30 mg/dl
3)HDL-C > 130 mg/dl
4)HDL-C < 25 mg/dl
5)TG > 1200 mg/dl
6)TG < 20 mg/dl
Key exclusion criteria
1) Patients with severe liver damage
2) Patients with severe kidney damage
3) Patients with severe metal disorder such as shizophrenia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Kurabayashi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Biological Science
Zip code
3718511
Address
3-35-19 Showa, Maebashi, Gunma , Japan
TEL
027-220-8145
mkuraba@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ohyama |
Organization
Gunma University Hospital
Division name
Clinical Investigation and Research Unit
Zip code
3718511
Address
3-35-19 Showa, Maebashi, Gunma , Japan
TEL
027-220-8740
Homepage URL
yoshiaki-ohyama@gunma-u.ac.jp
Sponsor or person
Institute
Gunma 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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15 Showa, Maebashi, Gunma, Japan
Tel
027-220-7111
hitotaisho-ciru@ml.gunma-u.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
| 2017 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
3
Results
3 patients were included. No mutation for dyslipidemia was detected.
Results date posted
| 2020 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
3 Patients who are suspected for ideopathic hyperlipidemia
Participant flow
written informed consent
Adverse events
none
Outcome measures
mutation for ideopathic hyperlipidemia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029083
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
