UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061493 |
|---|---|
| Receipt number | R000070363 |
| Scientific Title | Molecular analysis of liver disease progression and biomarker exploration using human liver samples |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/08 16:05:11 |
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Basic information
Public title
Exploration of liver disease progression pathways and identification of novel biomarkers
Acronym
Exploring liver disease progression biomarkers
Scientific Title
Molecular analysis of liver disease progression and biomarker exploration using human liver samples
Scientific Title:Acronym
Molecular and biomarker exploration in liver diseases
Region
| Japan |
Condition
Condition
Liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To establish a scientific foundation for the development of positron emission tomography(PET) based diagnostic and therapeutic strategies for liver diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationships between liver disease stages and molecular expression profiles, and correlation between histopathological parameters and molecular expression levels.
Key secondary outcomes
Variations in molecular network and stage associated expression changes of specific molecules and cellular subsets in liver disease.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Human liver samples obtained from brain dead donors, consisting of transplant ineligible livers for which consent for research use was obtained, together with accompanying clinical information.
Key exclusion criteria
Samples that do not meet the quality requirements for reliable molecular analyses
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Lin |
| Middle name | |
| Last name | Xie |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Advanced Nuclear Medicine Sciences, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Ingake-ku, Chiba
TEL
0432064039
xie.lin@qst.go.jp
Public contact
Name of contact person
| 1st name | Lin |
| Middle name | |
| Last name | Xie |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Advanced Nuclear Medicine Sciences, Institute for Quantum Medical Science
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku
TEL
0432064039
Homepage URL
xie.lin@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
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
National Institutes for Quantum Science and Technology Certificated Review Board
Address
4-9-1 Anagawa, Ingake-ku, Chiba
Tel
0432064706
helsinki@qst.go.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
| 2026 | Year | 05 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted as a retrospective observational study using existing human liver samples and their accompanying clinical information.
Management information
Registered date
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070363
