UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039573 |
|---|---|
| Receipt number | 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 01:08:40 |
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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
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
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045131
