UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058561 |
|---|---|
| Receipt number | R000066925 |
| Scientific Title | Multicenter observational study on the treatment outcomes of colorectal cancer |
| Date of disclosure of the study information | 2025/07/23 |
| Last modified on | 2025/07/23 13:14:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter observational study on the treatment outcomes of colorectal cancer
Acronym
Multicenter observational study on the treatment outcomes of colorectal cancer
Scientific Title
Multicenter observational study on the treatment outcomes of colorectal cancer
Scientific Title:Acronym
Multicenter observational study on the treatment outcomes of colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compare surgical outcomes for colorectal cancer at our hospital and affiliated facilities using open surgery, laparoscopic surgery, and robot-assisted surgery. We will evaluate the appropriateness of surgical indications and the efficacy and safety of laparoscopic surgery and robot-assisted surgery through a retrospective and prospective multicenter observational study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
5-year overall survival rate for each surgical approach (open, laparoscopic, robotic)
Key secondary outcomes
1. Five-year recurrence-free survival rates by surgical approach 2. Safety and efficacy of preoperative treatment (adverse events, treatment completion rate, response rate, recurrence-free survival period, cancer-specific survival period, overall survival period) 3. Incidence of postoperative complications by surgical procedure and approach, and identification of risk factors for postoperative complications4. Correlation between intraoperative findings and perioperative complications by surgical procedure 5. Incidence of postoperative abdominal wall hernia 6. Administration of postoperative adjuvant therapy and its details 7. Recurrence patterns and recurrence rates: Recurrence sites are classified as local recurrence, distant recurrence, or unknown as recurrence patterns. 8. Association between types of treatment after recurrence and long-term prognosis 9. Association between postoperative complications and long-term outcomes 10. Treatment outcomes in cases with organ invasion 11. Treatment outcomes in cases with concurrent distant metastasis 12. Treatment outcomes by surgical approach in obese patients 13. Treatment outcomes by surgical approach in elderly patients 14. Treatment outcomes of para-aortic lymph node dissection 15. Treatment outcomes in cases with comorbidities 16. Diagnostic accuracy of preoperative MRI for primary tumor depth and lateral lymph node metastasis 17. Short-term and long-term outcomes of lateral lymph node dissection 18. Lymph node dissection efficacy using the dissection index 19. Identification of risk factors for perioperative complications in ostomy and ostomy closure procedures 20. Association between aortic calcification volume measurement and perioperative complication incidence 21. Association between sarcopenia and perioperative complication incidence 22. Development of a predictive model using machine learning 23. Comparison of medical costs by surgical procedure and approach
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
Patients who meet all of the following criteria are eligible.
1) Patients diagnosed with colorectal cancer
2) Patients who have undergone surgical treatment
Key exclusion criteria
No exclusion criteria were set for this study.
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Kanechika |
| Middle name | |
| Last name | Den |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-6 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Tokyo
TEL
0457872800
den.kan.rw@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Ohya |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
2360004
Address
3-6 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2800
Homepage URL
t226020e@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Ethics Committee of Yokohama City University Hospital
Address
1-1-1 Fukuura kanazawa-ku Yokohama city
Tel
045-370-7627
ynext@yokohama-cu.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
| 2025 | Year | 07 | Month | 23 | 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
| 2024 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2039 | 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
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066925
