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

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 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

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

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
Registered date File name

Research case data
Registered date File name