UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051809 |
|---|---|
| Receipt number | R000059107 |
| Scientific Title | Cross-sectional study to estimate the proportion of suspected NASH in obese subjects |
| Date of disclosure of the study information | 2023/08/03 |
| Last modified on | 2023/08/09 10:19:19 |
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Basic information
Public title
Cross-sectional study to estimate the proportion of suspected NASH in obese subjects
Acronym
Cross-sectional study to estimate the proportion of suspected NASH in obese subjects
Scientific Title
Cross-sectional study to estimate the proportion of suspected NASH in obese subjects
Scientific Title:Acronym
Cross-sectional study to estimate the proportion of suspected NASH in obese subjects
Region
| Japan |
Condition
Condition
Nonalcoholic steato-hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the proportion of those with suspected NASH (liver stiffness >= 7.2 kPa) by FibroScan in obese subjects (BMI >= 25 kg/m2).
Basic objectives2
Others
Basic objectives -Others
liver stiffness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of subjects with suspected NASH based on the cutoff value for liver stiffness of 7.2kPa.
Key secondary outcomes
FAST score, FIB-4 Index, NFS, NAFIC , Fibro-Scope, NASH-scope
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obese subjects(BMI>=25kg/m2)
(1) The subjects who were understand the study protocol and written the consent to participate in this study.
(2) The subjects who were 18 years old or more at the time of obtain the informed consent.
Key exclusion criteria
(1)The subjects with a habitual pure ethanol intake of 30g/day or more (male) and 20g/day or more (female).
(2)The subjects who has other chronic liver diseases (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilson's disease, drug-induced liver injury (including fatty liver caused by corticosteroids) ), liver cirrhosis).
(3) The subjects who have a treatment or a history of malignant tumors of the hepatic/biliary system or pancreas.
(4) The subjects who were diagnosed with or treated for malignant tumors within 5 years before consent (excluding cancers that can be cured with topical treatment such as basal cell skin cancer, squamous cell carcinoma, and carcinoma in situ).
(5) The subjects who are being treated for or have a medical history of hepatitis B or C.
*Regarding medical history, the subjects, who were diagnosed with hepatitis B or C over 2 years ago and confirmed negative for antigen test, can participate in this study.
(6) The subjects who have a treatment for or a medical history of portal hypertension or liver failure (ascites, variceal bleeding, idiopathic bacterial peritonitis, hepatic encephalopathy).
(7) The subjects who have a history of liver transplantation.
(8) The subjects who are judged inappropriate for participation in this study by the principal investigator or co-investigator.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Tokyo Center Clinic. Medical corporation
Division name
President of the Hospital
Zip code
103-0028
Address
Yaesu KT Bldg, 1-1-8 Yaesu, Chuo-ku, Tokyo, Japan
TEL
0120-965-925
nagashima_hirotaka@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Takahira |
Organization
CMIC HealthCare Institute Co., Ltd
Division name
Dx division Med Reach Lab project management group
Zip code
105-0023
Address
HaHamamatsucho Bldg., 1-1-1 Shibaura Minato-ku, Tokyo, 105-0023
TEL
03-6779-8163
Homepage URL
maiko-takahira@cmicgroup.com
Sponsor or person
Institute
Tokyo Center Clinic. Medical corporation
Institute
Department
Personal name
Funding Source
Organization
Sawai Group Holdings Co.,Ltd.,
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-Kitamachi, Musashino-shi, Tokyo, 180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
交雄会新さっぽろ病院（北海道）、大阪府済生会吹田病院（大阪府）、原土井病院（福岡県）、関野病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 03 | 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
| 2023 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To estimate the proportion of those with suspected NASH (liver stiffness >= 7.2 kPa) by FibroScan in obese subjects (BMI >= 25 kg/m2)
Management information
Registered date
| 2023 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059107
