UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A fully-automated rapid detection system for detecting PNPLA3 (rs738409) single nucleotide polymorphisms associated with the prognosis of fatty liver
Title of the study (Brief title)	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
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	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	Yasunori Kawaguchi
Organization	Saga-Ken Medical Centre Koseikan
Division name	Department of Hepatobiliary and Pancreatology
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	Yasunori Kawaguchi
Organization	Saga-Ken Medical Centre Koseikan
Division name	Department of Hepatobiliary and Pancreatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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