UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024021 |
|---|---|
| Receipt number | 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 21:05:28 |
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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
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
| 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
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
kawaguy222@gmail.com
Sponsor or person
Institute
Saga-Ken Medical Centre Koseikan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027663
