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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040735
Receipt No. R000046504
Scientific Title Elucidation of pathological role of nuclear lipid droplets in liver disease
Date of disclosure of the study information 2020/12/31
Last modified on 2020/12/11

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Basic information
Public title Elucidation of pathological role of nuclear lipid droplets in liver disease
Acronym Elucidation of pathological role of nuclear lipid droplets in liver disease
Scientific Title Elucidation of pathological role of nuclear lipid droplets in liver disease
Scientific Title:Acronym Elucidation of pathological role of nuclear lipid droplets in liver disease
Region
Japan

Condition
Condition liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate pathological role of nuclear lipid droplets in liver disease
Basic objectives2 Others
Basic objectives -Others To elucidate pathological role of nuclear lipid droplets in liver disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of nuclear lipid droplet in liver biopsy samples
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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who perform liver biopsy
Key exclusion criteria Patients who disagree the study protocol
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Norihiro
Middle name
Last name Imai
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL 052-741-2169
Email norihiro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Norihiro
Middle name
Last name Imai
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya-shi
TEL 0527442169
Homepage URL
Email norihiro@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University Graduate School of Medicine, Institutional Review Board
Address 65 Tsurumai-cho, Showa-ku, Nagoya-shi
Tel 052-741-2111
Email ethics@med.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
2020 Year 12 Month 31 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 09 Month 01 Day
Date of IRB
2020 Year 09 Month 15 Day
Anticipated trial start date
2020 Year 09 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 Observational study (clinical data)

Management information
Registered date
2020 Year 06 Month 12 Day
Last modified on
2020 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046504

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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