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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044677
Receipt No. R000051025
Scientific Title Lipid metabolism and lipidomics analysis in patients with chronic liver disease: Multicenter cross-sectional study
Date of disclosure of the study information 2021/06/29
Last modified on 2021/06/28

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Basic information
Public title Observational study of lipid profile and lipid metabolism-related factors in chronic liver disease
Acronym Lipid analysis for chronic liver disease
Scientific Title Lipid metabolism and lipidomics analysis in patients with chronic liver disease: Multicenter cross-sectional study
Scientific Title:Acronym Lipidomics analysis for chronic liver disease
Region
Japan

Condition
Condition Non-viral chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Pathophysiology analysis of chronic liver disease using lipidomics and lipid metabolism analysis
Basic objectives2 Others
Basic objectives -Others Correlation of lipid profile in serum and liver tissue
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in lipid profile among chronic liver disease
Key secondary outcomes Differences in lipid metabolism and metabolites in each chronic liver disease

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age is 20 years or older at the time of consent acquisition
2) Those who have received sufficient explanation before participating in this research, and after sufficient understanding, have obtained the voluntary written consent of the research subject.
Key exclusion criteria 1) Those who have difficulty obtaining consent from the person
2) Those who are judged by the principal investigator to be inappropriate as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuyoshi
Middle name
Last name KON
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email kazukon@juntendo.ac.jp

Public contact
Name of contact person
1st name Kazuyoshi
Middle name
Last name KON
Organization Juntendo University School of Medicine
Division name Department of Gastroenterology
Zip code 1138421
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email kazukon@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization OSAKE-NO-KAGAKU
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo Clinical Research and Trial Center
Address 3-1-3 Hongo Bunkyo-ku, Tokyo
Tel 03-5802-1584
Email hongo-rinri@juntendo.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
2021 Year 06 Month 29 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
2021 Year 05 Month 07 Day
Date of IRB
2021 Year 05 Month 07 Day
Anticipated trial start date
2021 Year 05 Month 07 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation details:
(1) Obtain consent from patients with chronic liver disease and patients with metastatic liver disease who are scheduled to undergo liver biopsy or hepatectomy at our hospital and participating facilities.
(2) Patient background of each case, hematological data, Fibroscan test value, Inbody body composition value, presence / absence of liver cancer, course of treatment for metabolic syndrome-related diseases (dyslipidemia, hypertension, diabetes) Gather information about, nutrition, and drinking history.
(3) After obtaining consent, collect blood and serum for research at the same time before and after liver biopsy. In addition, one puncture sample is collected as a research sample at the time of liver biopsy. For surgery, a part of the liver tissue excised for diagnosis and treatment is used.
(4) Using the serum and liver tissue collected for research, perform target analysis (lipidomics analysis) of lipid composition using liquid chromatography + mass spectrometer in the laboratory of Juntendo University. DNA is extracted from the leukocyte fraction of the collected blood, DNA methylation (epigenome analysis) of lipid metabolism-related genes is performed by the bisulfite sequence method, and it has been said that it is related to the pathological condition of NAFLD by real-time PCR method. Single nucleotide polymorphisms (MBOAT7, PNPLA3, TM6SF2) and lipid-metabolizing enzymes FADS1 and FADS2 will be analyzed. In addition, unstained paraffin sections are prepared from liver biopsy tissue and immunohistochemically stained.


Management information
Registered date
2021 Year 06 Month 28 Day
Last modified on
2021 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051025

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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