UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047841 |
|---|---|
| Receipt number | R000054543 |
| Scientific Title | Prognosis of lung metastases of colorectal cancer |
| Date of disclosure of the study information | 2022/05/24 |
| Last modified on | 2025/05/26 11:58:19 |
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Basic information
Public title
Prognosis of lung metastases of colorectal cancer
Acronym
Prognosis of lung metastases of colorectal cancer
Scientific Title
Prognosis of lung metastases of colorectal cancer
Scientific Title:Acronym
Prognosis of lung metastases of colorectal cancer
Region
| Japan |
Condition
Condition
lung metastases of colorectal cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify prognostic factor of lung metastases of colorectal cancer
Basic objectives2
Others
Basic objectives -Others
To survey the recurrence after resection for lung metastases of colorectal cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival of lung metastases of colorectal cancer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgical treatment for lung metastases of colorectal cancer
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagasaki University Hospital
Division name
Surgical oncology
Zip code
8528511
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
0958197304
s.hashi12@outlook.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Hashimoto |
Organization
Nagasaki University Hospital
Division name
Surgical oncology
Zip code
8528511
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
0958197304
Homepage URL
s.hashi12@outlook.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nagasaki University Hospital
Address
1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
Tel
0958197304
s.hashi12@outlook.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 | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00423-023-03209-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00423-023-03209-4
Number of participants that the trial has enrolled
151
Results
1-, 3-, 5-year RFS: 75.1%, 53.7%, 51.1%; OS: 97.7%, 87.5%, 68.2%. Multivariate analysis: lymph node metastasis predicted poor RFS (HR 1.683, p=0.049), prior extrapulmonary metastasis (e-PM) resection predicted poor OS (HR 2.328, p=0.021). Early recurrence (<6 months) after PM resection linked to worse OS (50.8% vs. 90.2%, p=0.002); e-PM history predicted early recurrence (OR 3.989, p=0.049).
Results date posted
| 2023 | Year | 05 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who underwent resection for pulmonary metastases
Participant flow
It is a retrospective observational study of routine clinical practice, and routine care is being continued.
Adverse events
None
Outcome measures
Overall survival, Rerapse free survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We survey the clinical and surgical record of the patients who experienced surgical treatment for lung metastases of colorectal cancer.
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054543
