UMIN-CTR Clinical Trial

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