UMIN-ICDS Clinical Trial

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

Nonalcoholic Fatty Liver Disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Selection of biomarker candidates related with liver fibrosis by metabolome analysis in sebum components

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

clinical-trials@chugai-pharm.co.jp

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

Email

clinical-trials@chugai-pharm.co.jp

Institute

Chugai Pharmaceutical Co., Ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Oita university ethical committee

Address

1-1 Idaigaoka, Hasama-cho, Yufu city, Oita

Tel

097-586-6380

Email

rinrikenkyu@oita-u.ac.jp

Secondary IDs

NO

Study ID_1

-

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大分大学医学部附属病院(大分県)

Date of disclosure of the study information

2023

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000052380