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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027868
Receipt No. 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

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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
Email 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
Email yoshiaki-ohyama@gunma-u.ac.jp

Sponsor
Institute Gunma 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 Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address 3-39-15 Showa, Maebashi, Gunma, Japan
Tel 027-220-7111
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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