UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044677 |
|---|---|
| Receipt number | 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 01:47:40 |
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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
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
kazukon@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051025
