UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046016 |
|---|---|
| Receipt number | R000052524 |
| Scientific Title | Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index]) |
| Date of disclosure of the study information | 2021/11/10 |
| Last modified on | 2024/09/02 09:47:04 |
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Basic information
Public title
Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index])
Acronym
Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index])
Scientific Title
Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index])
Scientific Title:Acronym
Investigation of correlation between the two indexes used to determine the progression of pathological conditions in liver disease (the FIB4 index [an index of progression of liver fibrosis] and the liver fibrosis stage as assessed by FibroScan [a liver fibrosis staging index])
Region
| Japan |
Condition
Condition
Nonalcoholic steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To calculate the FIB4 index (an index of progression of liver fibrosis) in individuals who meet any of the following three criteria: 1. Those with a diagnosis of nonalcoholic steatohepatitis (NASH); 2. those with suspected nonalcoholic fatty liver disease (NAFLD); and 3. those with a high possibility of having NAFLD. In addition, a FibroScan (to measure liver stiffness and liver fat mass), which determines the stage of liver fibrosis, will be performed to understand the correlation (distribution) between the FIB4 index and the liver fibrosis staging index based on FibroScan results. Furthermore, the number of individuals with a high level of fibrosis (F3) among those with an intermediate FIB4 index or higher will be examined.
In addition, we will investigate the sex and age distribution of the FIB4 index levels and the presence of diabetes and dyslipidemia, which are said to be risk factors in addition to obesity for NAFLD and NASH. The FIB4 index as well as the liver fibrosis stage and liver fat levels as assessed by FibroScan will be tabulated and examined according to the presence or absence of diabetes and dyslipidemia.
Basic objectives2
Others
Basic objectives -Others
A non-interventional prospective observational study
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To understand the correlation between the FIB4 index and liver fibrosis stage as assessed by FibroScan and to examine how many individuals have a high level of fibrosis (F3) among those with an intermediate FIB4 index or higher.
Key secondary outcomes
(1) To examine the sex and age distribution of the FIB4 index levels and clarify how to determine an appropriate cut-off value for the FIB4 index for each age group.
(2) To tabulate and examine the FIB4 index as well as the liver fibrosis stage and liver fat levels as assessed by FibroScan, according to the presence or absence of diabetes and dyslipidemia in study participants who have these complications.
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) Those who are 20 years old or older at the first visit
2) Those who can provide written informed consent for participation in the study
3) Those who have a mean alcohol intake of 30 g/day or less for men and 20 g/day or less for women in the last 3 months and those who have no history of drinking alcohol
4) Those who meet any of the following conditions:
-1.Those with a diagnosis of NASH
-2.Those with suspected NAFLD
-3.Those with a high possibility of having NAFLD who meet any of the following conditions:
- FIB4 index of 1.3 or higher
- Age 35 years old or older and BMI of 25 kg/m2 or more and/or triglyceride (TG) level of 150 mg/dL or more
Key exclusion criteria
1) Those with a history or suspected history of alcoholic liver disease. Significant alcohol intake within 2 years prior to informed consent (mean intake above 210 g/week for men and above 140 g/week for women) for more than 3 consecutive months.
2) Medical history of other chronic liver diseases (viral hepatitis, autoimmune liver disease, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, A1AT deficiency, treatment history of liver transplantation, etc.)
3) Suspected, diagnosed, or history of hepatocellular carcinoma or active, suspected, or history of malignant tumor within 5 years before screening ; however, patients with appropriately treated basal cell carcinoma of the skin or cervical carcinoma in situ do not need to be excluded.
4) Diagnosis of serious or unstable disease of the liver (other than NASH), kidney, digestive organs, respiratory organs, cardiovascular system (including ischemic heart disease) or endocrine, neurological, mental, immune, or blood disorders or other medical conditions that may affect the investigations in this study according to the clinical judgment of the principal investigator.
5) Those who are pregnant or who use a pacemaker.
Target sample size
3150
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Medical Corporation Chiseikai
Tokyo Center Clinic
Division name
Clinical Research Center
Zip code
1030028
Address
KT Bldg.2F, 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
0332766935
nagashima_hirotaka@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Medical Corporation Chiseikai Tokyo Center Clinic
Division name
Clinical Research Group
Zip code
1030028
Address
KT Bldg.2F, 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
0332766935
Homepage URL
nagashima_hirotaka@tc-clinic.jp
Sponsor or person
Institute
Medical Corporation Chiseikai
Tokyo Center Clinic
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-profit organization Tokyo Allergy and Respiratory Disease Research Institute
Address
Riverside Tower Kuramae 3F, 1-8-6 Kuramae,Taito-ku,Tokyo
Tel
080-7360-0910
info@inclusion-p.com
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
1. 東京センタークリニック（東京都）、新宿しまだ内科クリニック（東京都）、東長崎駅前内科クリニック（東京都）
TOKYO CENTER CLINIC (Tokyo), Shinjuku-Shimada-Naika-Clinic (Tokyo), Higashinagasakiekimae Medical Clinic (Tokyo)
2. 医療法人京星会JOHメディカルクリニック（大阪府）、大阪公立大学医学部附属病院 先端予防医療部附属クリニック MedCity21（大阪府）
JOH Medical Clinic (Osaka), Osaka Metropolitan University Hospital Advanced Medical Center for Preventive Medicine MedCity21 (Osaka)
3. 山下司内科クリニック（福岡県）、独立行政法人国立病院機構 九州医療センター（福岡県）、大博通り内科・総合診療クリニック（福岡県）
Yamashita Tsukasa Clinic (Fukuoka), National Hospital Organization Kyushu Medical Center (Fukuoka), Taihaku Avenue Clinic (Fukuoka)
4. 医療法人バームリンデンはやせ希望クリニック（愛知県）、藤田医科大学（愛知県）
Hayase kibou Clinic (Aichi), Fujita Health University (Aichi)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 10 | 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
7645
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 30 | Day |
Other
Other related information
NAFLD has been reported to be closely associated with obesity and has been increasing rapidly in Japan in recent years against the backdrop of rising numbers of people with obesity, which has led to an increase also in NASH.
Regarding the diagnosis of NASH, histological diagnosis by a liver biopsy is widely accepted as being highly accurate; however, because liver biopsy is an invasive procedure, it is performed only after careful consideration whether it is required or not. On the other hand, a US meta-analysis showed that liver fibrosis is the most important factor contributing to the prognosis of NAFLD, and in recent years, non-invasive liver fibrosis indicators are being considered as an alternative to invasive liver biopsy. The FIB4 index is useful for assessing the progression of liver fibrosis, and FibroScan is useful for determining the stage of liver fibrosis.
However, there is little evidence on the correlation (distribution) between the FIB4 index and the liver fibrosis stage as assessed by FibroScan. Therefore, clarifying the prevalence of individuals with a high level of fibrosis (F3) among those with an intermediate FIB4 index or higher in Japan will lead to more effective recognition by non-invasive indicators of latent NASH and NAFLD with a high level of fibrosis.
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052524
