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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039573
Receipt No. R000045131
Scientific Title PNPLA3 genotype and risk of complication in liver cirrhosis
Date of disclosure of the study information 2020/02/24
Last modified on 2020/02/23

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Basic information
Public title PNPLA3 genotype and risk of complication in liver cirrhosis
Acronym PNPLA3 genotype and risk of complication in liver cirrhosis
Scientific Title PNPLA3 genotype and risk of complication in liver cirrhosis
Scientific Title:Acronym PNPLA3 genotype and risk of complication in liver cirrhosis
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to assess the influence of PNPLA3 for the severity of liver cirrhosis (LC).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We examined the association between the distribution of PNPLA3 rs738409 alleles and the complication of liver cirrhosis.
Key secondary outcomes

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 Liver cirrhosis based on laboratory results and imaging tests
Key exclusion criteria Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Haruki
Middle name
Last name Uojima
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL +81-42-778-8111
Email kiruha@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Haruki
Middle name
Last name Uojima
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
TEL +81-42-778-8111
Homepage URL
Email kiruha@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine
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 Kitasato University Institutional Review Board
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa Japan
Tel +81-42-778-8111
Email rinrib@med.kitasato-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
2020 Year 02 Month 24 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
2020 Year 01 Month 11 Day
Date of IRB
2020 Year 01 Month 10 Day
Anticipated trial start date
2020 Year 02 Month 16 Day
Last follow-up date
2023 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Genotyping for polymorphism PNPLA3 (rs738409, rs2896019) was performed using TaqMan SNP Genotyping Assays (Applied Biosystems, Waltham, USA) and the LightCycler 96 System (Roche).

Management information
Registered date
2020 Year 02 Month 23 Day
Last modified on
2020 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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