UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047356 |
|---|---|
| Receipt number | R000054014 |
| Scientific Title | A prospective observational study on lymph node metastasis in right-sided colon cancer |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/02 09:31:31 |
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Basic information
Public title
A prospective observational study on lymph node metastasis in right-sided colon cancer
Acronym
Right-sided colon cancer study
Scientific Title
A prospective observational study on lymph node metastasis in right-sided colon cancer
Scientific Title:Acronym
Right-sided colon cancer study
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine long term survival and the frequency and location of lymph node metastasis and the short-term results of radical surgery with extended lymph node dissection for right-sided colon cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency and location of lymph node metastasis
Key secondary outcomes
Long term survival
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)Primary tumour located in the caecum, ascending colon, or right side of the transverse colon; (2)stage II or III disease according to the Union for International Cancer Control TNM Classification of Malignant Tumours (8th edition); (3) mainly lymph nodes around the SMA and SMV to be dissected, and (4) a longitudinal resection margin >10 cm beyond the tumour on both the oral and anal sides planned.
Key exclusion criteria
Patients with a history of chemotherapy or multiple cancers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Kanemitsu |
Organization
National cancer center hospital
Division name
Department of Colorectal Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3547-5201
ykanemit@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Tsukamoto |
Organization
National cancer center hospital
Division name
Department of Colorectal Surgery
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
+81-3-3547-5201
Homepage URL
https://www.ncc.go.jp/jp/ncch/
shtsukam@ncc.go.jp
Sponsor or person
Institute
National Cancer center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aichi Cancer Center Hospital
Kanagawa Cancer Center Hospital
Osaka International Cancer Institute Hospital
Niigata Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
+81335422511
irst@ml.res.ncc.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
| 2022 | Year | 04 | Month | 01 | 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
208
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary endpoint was the metastasis rate at each lymph node station according to tumour location and main feeding artery. Secondary endpoints were postoperative complications, the R0 resection rate, 5-year overall survival, and 5-year relapse-free survival according to metastatic status in each node station. This report summarizes the short-term outcomes; overall survival and relapse-free survival rates will be reported after 5 years of follow-up.
Management information
Registered date
| 2022 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054014
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
