UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059404 |
|---|---|
| Receipt number | R000067890 |
| Scientific Title | Treatment strategies of colorectal liver metastases |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 00:08:32 |
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Basic information
Public title
Treatment strategies of colorectal liver metastases
Acronym
Treatment strategies of colorectal liver metastases
Scientific Title
Treatment strategies of colorectal liver metastases
Scientific Title:Acronym
Treatment strategies of colorectal liver metastases
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Surgical treatment remains the most reliable approach for liver metastases from colorectal cancer. However, complications associated with liver resection can sometimes lead to severe outcomes and patient detriment. Therefore, determining which cases warrant liver resection and the optimal timing for the procedure are critically important. We retrospectively compiled cases of liver metastasis resection from colorectal cancer treated at the Department of General Surgery, Shimane University Hospital (hereinafter referred to as our department). We analyzed factors influencing treatment efficacy and outcomes to inform future clinical research and the development of optimal treatment strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Incidence rate of adverse events (adverse reactions)
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
1) Individuals diagnosed with colorectal cancer liver metastases via imaging studies (Dynamic CT and MRI examinations) between January 2017 and June 2024.
2) No restrictions on age or gender.
3) No restrictions on the number of liver metastases.
4) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) < 2.
5) Child-Pugh score: 5 to 9 (Grade A~B).
Key exclusion criteria
None
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Shimane University Faculty of Medicine.
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
Enya-cho 89-1, Izumo City, Shimane Prefecture
TEL
0853-20-2232
taniura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Taniura |
Organization
Shimane University Faculty of Medicine.
Division name
Department of Digestive and General Surgery
Zip code
693-8501
Address
Enya-cho 89-1, Izumo City, Shimane Prefecture
TEL
0853202232
Homepage URL
taniura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine.
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
Shimane University Hospital Clinical Research Center, Clinical Research Support Division
Address
Enya-cho 89-1, Izumo City, Shimane Prefecture
Tel
0853-20-2515
kenkyu@med.shimane-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
島根県
Institutions
Institutions
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | 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
Currently collecting case data
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067890
