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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038707
Receipt No. R000044130
Scientific Title multicenter study for treatment of colon cancer
Date of disclosure of the study information 2019/11/30
Last modified on 2020/03/24

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Basic information
Public title multicenter study for treatment of colon cancer
Acronym multicenter study for treatment of colon cancer
Scientific Title multicenter study for treatment of colon cancer
Scientific Title:Acronym multicenter study for treatment of colon cancer
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze the 5-year overall survival of laparoscopic surgery for colon cancer, and compared to open surgery for colon cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year overall survival rate of laparoscopic and open surgery for colon cancer
Key secondary outcomes 1.To investigate the comparison of 5-year disease free survival rate between laparoscopic surgery and open surgery.
2.To investigate the safety and effectivity for preoperative treatment (adverse event, completion rate, response rate, disease-free survival time, overall survival time, et al.)
3. To investigate the operative procedures, postoperative complication rates and the risk factors for postoperative complications.
4.To investigate the postoperative incisional hernia.
5. To investigate the effect of postoperative adjuvant chemotherapy.
6. To investigate the recurrence site and treatment after surgery.
7. To investigate the impact of postoperative complications for long-term outcomes.
8. To investigate the outcomes for the cases with clinical T4b(invasion to adjacent organs).
9. To investigate the outcomes for the cases with distant metastases (clinical Stage IV).
10.To investigate the surgical outcomes for the obesity cases(BMI, SFA, VFA)
11. To investigate the outcomes of laparoscopic surgery for elderly cases.
12. To investigate the outcomes for the cases with paraaortic lymph node dissection.
13. To investigate the outcomes for the cases with comorbidity(cardiac disease, pulmonary disease, antiplatelet therapy, anticoagulant therapy).
14. To investigate the effectiveness of lymph node dissection using lymph node dissection index.
15. Subgroup analysis: To analyze the above outcomes by tumor locations, pathological stages et al.


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 the cases who had pathologically adenocarcinoma, and were undergone surgery.
Key exclusion criteria judgement not to register suitably.
Target sample size 12000

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Watanabe
Organization Yokohama city university medical center
Division name Center of gastroenterology
Zip code 2320024
Address 4-57 Urafune, Minami-ku, Yokohama
TEL 0452615656
Email jun0926@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Midori
Middle name
Last name Tominaga
Organization Yokohama city university
Division name Y-NEXT
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 0457872800
Homepage URL
Email ynext@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university
Institute
Department

Funding Source
Organization no funding source
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 Yokohama city university
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
Tel 0457872800
Email t196056a@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 11 Month 30 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 315
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 No longer recruiting
Date of protocol fixation
1992 Year 08 Month 01 Day
Date of IRB
2018 Year 02 Month 01 Day
Anticipated trial start date
1992 Year 08 Month 06 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information postoperative incisional hernia

Management information
Registered date
2019 Year 11 Month 28 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044130

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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