UMIN-CTR Clinical Trial

Basic information
Public title	Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Acronym	Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Scientific Title	Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Scientific Title:Acronym	Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Region	Japan

Condition
Condition	Chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate clinical impact of UBXD8 gene polymorphism on the pathogenesis of alcoholic liver diseases
Basic objectives2	Others
Basic objectives -Others	To evaluate clinical impact of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical impact of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
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	Gene
Interventions/Control_1	Obtain additional blood sample (6mL)
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who are currently receiving treatment for chronic liver disease at our hospital Patients who understand the contents of this study and have given written consent to participate in the study.
Key exclusion criteria	Patients who wish to be excluded from the study If the principal investigator determines that the patient is ineligible to participate in the study for any other reason.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Imai
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL	0527442169
Email	norihiro@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Norihiro Middle name Last name Imai
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL	0527442169
Homepage URL
Email	norihiro@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Hospital
Address	65 Tsurumai-cho, Showa-u, Nagoya-shi
Tel	0527442061
Email	iga-shinsa@adm.nagoya-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

Other administrative information
Date of disclosure of the study information	2022 Year 04 Month 01 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 12 Month 31 Day
Date of IRB	2021 Year 12 Month 15 Day
Anticipated trial start date	2022 Year 01 Month 01 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

Management information
Registered date	2021 Year 10 Month 16 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052253