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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030331
Receipt No. R000034640
Scientific Title Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery
Date of disclosure of the study information 2017/12/12
Last modified on 2019/06/24

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Basic information
Public title Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery
Acronym Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery
Scientific Title Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery
Scientific Title:Acronym Prospective Study for Optimal Length of Bowel Resection in Colon Cancer Surgery
Region
Japan

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

Objectives
Narrative objectives1 To clarify the actual status of metastatic LN distribution in colon cancer and identify the optimal length of bowel resection in colon cancer surgery
Basic objectives2 Others
Basic objectives -Others To obtain evidence for standardized colon cancer surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Distribution and incidence of metastatic lymph nodes
Key secondary outcomes Incidence of recurrence according to the length of bowel resection

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. Histologically proven colon adenocarcinoma
2. Pathological stage I, II or III
3. Pericolic regional lymph nodes are dissected according to the Japanese Classification of Colorectal Carcinoma (7th edition)
4. Bowel resection at 10 cm or more from a tumour edge
5. Informed consent for observational data collection
Key exclusion criteria 1. Patients with preoperative chemotherapy
2. Multiple colon cancer (excluding Tis)
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Kazuo
Middle name
Last name Hase
Organization National Defense Medical College
Division name Department of Surgery
Zip code 359-8513
Address 3-2, Namiki, Tokorozawa, Saitama
TEL 04-2995-1637
Email kazuh@ndmc.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Ueno
Organization National Defense Medical College
Division name Department of Surgery
Zip code 359-8513
Address 3-2, Namiki, Tokorozawa, Saitama
TEL 04-2995-1637
Homepage URL http://www.jsccr.jp/project/proj_coloncancer.html
Email ueno_surg1@ndmc.ac.jp

Sponsor
Institute Japanese Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization Japanese Society for Cancer of the Colon and Rectum
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 Institutional Review Board, Japanese Society for Cancer of the Colon and Rectum
Address Sanbancho KS Bldg., 2 Sanbancho, Chiyoda-ku, Tokyo 102-0075, Japan
Tel 03-3263-8697
Email jsccr@secretariat.ne.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 恵佑会札幌病院(北海道)、山形県立中央病院(山形県)、新潟県立がんセンター新潟病院(新潟県)、国立がん研究センター東病院(千葉県)、帝京大学ちば総合医療センター(千葉県)、防衛医科大学校(埼玉県)、栃木県立がんセンター(栃木県)、埼玉県立がんセンター(埼玉県)、国立がん研究センター中央病院(東京都)、東京医科歯科大学大学院(東京都)、帝京大学医学部(東京都)、がん・感染症センター駒込病院(東京都)、杏林大学医学部付属病院(東京都)、東京女子医科大学(東京都)、横浜市立大学医学部(神奈川県)、済生会横浜市南部病院(神奈川県)、神奈川県立がんセンター(神奈川県)、横浜市立大学付属市民総合医療センター(神奈川県)、静岡県立静岡がんセンター(静岡県)、愛知県立がんセンター中央病院(愛知県)、藤田保健衛生大学(愛知県)、三重大学大学院医学系研究科(三重県)、滋賀医科大学(滋賀県)、大阪国際がんセンター(大阪府)、和歌山県立医科大学(和歌山県)、久留米大学(福岡県)、大腸肛門病センター高野病院(熊本県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 12 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Study design:
Multicenter prospective cohort study

2. Patient recruitment:
All patients with colon cancer surgery between June 2013 and December 2017 at the participating institutions who satisfy the selection criteria for this study.

3. Parameters collected:
Patient characteristics
-Age
-Gender
-Height
-Weight

Tumor characteristics
-Tumor location
-pT stage
-Differentiation grade

Surgery-related characteristics
-Year and month of surgery
-Surgical method
-Intraoperative marking for measurement (under direct vision / laparoscopic)
-Resection margin

Items associated with feeding artery
-Accuracy of intraoperative identification
-Pattern of distribution
-Distance from the primary tumor

Lymph node (LN) distribution
-Number of LNs retrieved and involved LNs according to LN region

Prognostic outcomes
-Year and month of last follow-up
-Prognostic outcomes and cause of death
-Year and month of recurrence
-Recurrence pattern

Management information
Registered date
2017 Year 12 Month 10 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034640

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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