UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030885 |
|---|---|
| Receipt number | R000035265 |
| Scientific Title | Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer |
| Date of disclosure of the study information | 2018/01/18 |
| Last modified on | 2021/01/22 09:33:24 |
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Basic information
Public title
Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Acronym
Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Scientific Title
Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Scientific Title:Acronym
Lymphadenectomy around ileocolic artery and vein for advanced right-sided colon cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the metastatic lymph nodes around ileocolic artery and vein for advanced right-sided colon cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
metastasis rate of lymph nodes around ileocolic artery and vein
Key secondary outcomes
None
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 with radical surgery for advanced right-sided colon cancer
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
shiozawam@kcch.jp
Public contact
Name of contact person
| 1st name | Sumito |
| Middle name | |
| Last name | Sato |
Organization
Kanagawa Cancer Center
Division name
Department of Gastrointestinal Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL
045-520-2222
Homepage URL
su.sato@kcch.jp
Sponsor or person
Institute
Kaagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Canecer Center
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
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
Tel
0455202222
chiken-jim4@kcch.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
| 2018 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00423-020-02016-5
Number of participants that the trial has enrolled
91
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 21 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study to decide the properly lymphadenectomy area around ileocolic artery and vein for advanced right-sided colon cancer
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035265
| 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 |
