UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050863 |
|---|---|
| Receipt number | R000052380 |
| Scientific Title | Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2023/06/30 19:13:58 |
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Basic information
Public title
Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples
Acronym
Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples
Scientific Title
Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples
Scientific Title:Acronym
Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples
Region
| Japan |
Condition
Condition
Nonalcoholic Fatty Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers for liver fibrosis from sebum components
Basic objectives2
Others
Basic objectives -Others
Exploratory Biomarker research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Selection of biomarker candidates related with liver fibrosis by metabolome analysis in sebum components
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To apply a tape to collect sebum on the site of collection (forehead, neck, precordium) for long times.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Common items:
The contents of the present research have been sufficiently explained, and their written voluntary consent has been obtained.
- >= 18 to =< 70 years
For healthy adult volunteers:
- without fatty liver
- Not to have any disease requiring outpatient visits and am healthy.
- Normal renal function
For patients with nonalcoholic fatty liver disease:
- diagnosed with hepatic steatosis or steatohepatitis in the past
- The subject has fatty deposits in the liver confirmed by abdominal ultrasound performed within 6 months prior to the day of sebum collection.
Key exclusion criteria
Common items:
- Ethanol hypersensitivity
- Persons who have experienced skin irritation by adhesive tapes
- Alcohol consumption >= 30 g/day (males) or >= 20 g/day (females).
- Taking supplements such as vitamin and Minerals within 1 week of the day of sample collection (However, drugs including vitamins and minerals that are continuously used as therapeutic drugs for diseases are excluded.)
- Prior surgery of the pancreatic and gallbladder system
- Researchers involved in this research
- the doctor judges it difficult for you to participate
For healthy volunteers:
- Hepatobiliary disease and medical history
- Abdominal echo shows fatty liver
For patients with nonalcoholic fatty liver disease:
- Moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m^2)
- other hepatobiliary disorders are suspected; alcoholic liver disease, autoimmune liver disease, cholangitis, Alpha-1 antitrypsin deficiency, such as Wilson disease,
Drug-induced liver injury, viral liver diseases such as HBV/HCV,
cirrhosis, liver cancer, previous intravenous drug administration within 1 month before sample collection, Thyroid and adrenal disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Yoshimura |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Pharmaceutical Science Dept.
Zip code
244-8602
Address
216 Totsukacho, Totsuka-ku, Yokohama City, Kanagawa, Japan
TEL
0120189706
clinical-trials@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Chugai Pharmaceutical Co., Ltd. |
| Middle name | |
| Last name | Clinical trials information |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Clinical Strategy and Resource Management Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo
TEL
0120189706
Homepage URL
clinical-trials@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical 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
Oita university ethical committee
Address
1-1 Idaigaoka, Hasama-cho, Yufu city, Oita
Tel
097-586-6380
rinrikenkyu@oita-u.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
大分大学医学部附属病院(大分県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 17 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052380
