UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045767 |
|---|---|
| Receipt number | R000052253 |
| Scientific Title | Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/10/17 17:01:07 |
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Basic information
Public title
Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Acronym
Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Scientific Title
Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Scientific Title:Acronym
Study on influence of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate clinical impact of UBXD8 gene polymorphism on the pathogenesis of alcoholic liver diseases
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical impact of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical impact of UBXD8 gene polymorphism on the pathogenesis of chronic liver diseases
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Obtain additional blood sample (6mL)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are currently receiving treatment for chronic liver disease at our hospital
Patients who understand the contents of this study and have given written consent to participate in the study.
Key exclusion criteria
Patients who wish to be excluded from the study
If the principal investigator determines that the patient is ineligible to participate in the study for any other reason.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL
0527442169
norihiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Imai |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL
0527442169
Homepage URL
norihiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
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
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-u, Nagoya-shi
Tel
0527442061
iga-shinsa@adm.nagoya-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
| 2022 | Year | 04 | Month | 01 | 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
| 2021 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052253
