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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024021
Receipt No. R000027663
Scientific Title A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Date of disclosure of the study information 2016/09/13
Last modified on 2016/09/12

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Basic information
Public title A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Acronym A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Scientific Title A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Scientific Title:Acronym A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Region
Japan

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

Objectives
Narrative objectives1 PNPLA3 (patatin-like phospholipase domain-containing 3) gene localized on human chromosome 22 encodes a protein known as adiponutrin, which is expressed in both adipocytes and hepatocytes. PNPLA3 protein affects energy mobilization and the storage of lipid droplets, because it has lipase activity against triglycerides. Recent studies have shown that the PNPLA3 SNPs are associated with the natural course of nonalcoholic fatty liver disease and alcoholic liver disease. The i-densyTM (Arkray, Inc.), which is based on the quenching probe (QP) method, automatically detects target genes in blood samples within 90 min. The aim of current study was to compare the utility of QP method with that of conventional direct sequencing for detecting SNPs in the PNPLA3 gene.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Consistency between the Quenching probe method and the Direct sequence method
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
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Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with fatty liver disease
Key exclusion criteria patient who cannot declare informed-consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Kawaguchi
Organization Saga-Ken Medical Centre Koseikan
Division name Department of Hepatobiliary and Pancreatology
Zip code
Address 400 Nakabaru, Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL 0952-24-2171
Email kawaguy222@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Kawaguchi
Organization Saga-Ken Medical Centre Koseikan
Division name Department of Hepatobiliary and Pancreatology
Zip code
Address 400 Nakabaru, Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL 0952-24-2171
Homepage URL
Email kawaguy222@gmail.com

Sponsor
Institute Saga-Ken Medical Centre Koseikan
Institute
Department

Funding Source
Organization Saga-Ken Medical Centre Koseikan
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
Address
Tel
Email

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
2016 Year 09 Month 13 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
2016 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The current study was performed to compare the utility of Quenching probe method with that of conventional direct sequencing for detecting the PNPLA3 gene SNPs in patients' blood sample.

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027663

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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