UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061904 |
|---|---|
| Receipt number | R000070836 |
| Scientific Title | Multi-omics study on host pathophysiology caused by cancer |
| Date of disclosure of the study information | 2026/06/14 |
| Last modified on | 2026/06/14 22:08:00 |
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Basic information
Public title
Multi-omics study on host pathophysiology caused by cancer
Acronym
Cancer-host multi-omics study
Scientific Title
Multi-omics study on host pathophysiology caused by cancer
Scientific Title:Acronym
Cancer-host multi-omics study
Region
| Japan |
Condition
Condition
Primary or metastatic malignant liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pathophysiological changes in host hepatocytes and stromal cells associated with malignant liver tumors by multi-omics analysis of surgically resected tissues, blood, bile, and ascites samples.
Basic objectives2
Others
Basic objectives -Others
Exploratory analysis of pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gene expression changes in host hepatocytes and stromal cells associated with malignant liver tumors, assessed by bulk RNA-seq and Xenium spatial gene expression analysis of surgically resected tissues
Key secondary outcomes
Associations between metabolite, cytokine, and peripheral blood mononuclear cell profiles in body fluid samples, including blood, and gene expression or spatial expression patterns in tissue samples
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
| 18 | years-old | <= |
Age-upper limit
| 999 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with malignant liver tumors
2. Patients who undergo or have undergone surgical resection at Tohoku University Hospital
3. Patients aged 18 years or older
4. For prospectively collected samples, patients who provide written informed consent to participate in this study
Key exclusion criteria
1. Patients who have not been informed that they have a malignant tumor
2. Patients who are unable to voluntarily provide informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinpei |
| Middle name | |
| Last name | KAWAOKA |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryo-machi Aobaku, Sendai
TEL
022-717-8568
shipnei.kawaoka.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Yoda |
Organization
Tohoku University
Division name
Instutite of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryo-machi Aobaku, Sendai
TEL
022-717-8568
Homepage URL
mayuko.yoda.e8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
JST
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
4-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8568
shinpei.kawaoka.c1@tohoku.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
| 2026 | Year | 06 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 06 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070836
