UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037195 |
|---|---|
| Receipt number | R000042393 |
| Scientific Title | Multicenter cohort study on lymph node metastasis region and frequency in splenic flexural colon cancer |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2022/12/12 00:58:33 |
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Basic information
Public title
Multicenter cohort study on lymph node metastasis region and frequency in splenic flexural colon cancer
Acronym
SP study
Scientific Title
Multicenter cohort study on lymph node metastasis region and frequency in splenic flexural colon cancer
Scientific Title:Acronym
SP study
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to survey the status of lymph node metastasis to the accessory middle colon artery region in splenic flexural colon cancer and to clarify whether it is meaningful to dissect as the main artery as well as the middle colon artery and left colon artery .
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of lymph node metastassis to the accessory middle colic artery
Key secondary outcomes
Frequency of lymph node metastassis to the middle colic artery and left colic artery
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
1.Patients who are 20 years old or older
2 Patients with histologically proven colon cancer
3 The central part of the tumor is within 10 cm from the splenic flexure
4 patients diagnosed with cStage1-3 by preoperative imaging
5 Patients scheduled to undergo lymph node dissection with D2 or greater. However, even if D0/D1 dissection is performed during surgery, it is not excluded.
Key exclusion criteria
1 Patients with distant metastasis. However, we do not exclude cases where distant lesions are pointed out accidentally during surgery.
2 Patients with multiple cancer (except for Tis lesions)
3 Patients with a history of colorectal cancer resection
Target sample size
139
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Department of surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho,Minami-ku,Yokohama
TEL
045-261-5656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Department of surgery, Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho,Minami-ku,Yokohama
TEL
045-261-5656
Homepage URL
nabe-jun@comet.ocn.ne.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Yokohama City University
Address
3-9, Fukuura Kanazawa-ku Yokohama
Tel
045-787-2800
rinri@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
| 2019 | Year | 06 | Month | 27 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For removed specimens in surgical treatment
1) Unfold the extracted sample in vivo and fix it on a plate with a pin. Mark the stump at the blood vessel and the junction with the marginal artery.
2) The lymph nodes are searched while clarifying the dominant blood vessels and the marginal arteries, and pathological diagnosis based on Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma is performed.
3) Classify the lymph nodes according to the definition, including the presence of the accessory middle colon artery.
Management information
Registered date
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042393
| Research Plan | |
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| 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 |
