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International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer (T-REX)

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ClinicalTrials.gov Identifier: NCT02938481
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Tokyo Medical and Dental University, Japan
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary:
The T-REX study aims to clarify the actual status of metastatic lymph node (LN) distribution in colon cancer and provide reliable evidence regarding the optimal length of bowel resection and the extent of central lymph node dissection in colon cancer surgery.

Condition or disease
Colon Cancer

Detailed Description:

In colon canser, the incidence of metastasis in the pericolic lymph nodes (LNs) located along the bowel and marginal artery is high. The optimal extent of bowel resection is closely associated with how we define 'regional' pericolic LNs, which should be resected because of the risk of metastasis. However, there are no standardised criteria for 'regional' LNs in the pericolic area.

To establish a consensus for the extent of bowel resection and appropriate central LN dissection, international prospective stdies focusing on the distribution of metastatic LNs along the bowel and the primary feeding artery are conducted.


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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
Actual Study Start Date : January 22, 2015
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023



Primary Outcome Measures :
  1. Distribution of metastatic LNs [ Time Frame: At the time of patient registry in ]

Secondary Outcome Measures :
  1. Prognostic outcomes according to the length of bowel resection [ Time Frame: 3 years ]
  2. Prognostic outcomes according to the central radicality [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
  • Resected surgical specimens to take photographs
  • Lymph nodes retrieved from Resected surgical specimens to categorise


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colon cancer who will receive potentially curative surgery at participating institutions between 22 Jan 2015 and 22 Jan 2020.
Criteria

Inclusion Criteria:

  • Histologically proven colon adenocarcinoma
  • Pathological stage Ⅰ, Ⅱ or Ⅲ
  • Potentially curative surgery
  • Informed consent for observational data collection

Exclusion Criteria:

  • Tis (mucosal cancer)
  • Multiple colon cancers
  • All patients with preoperative adjuvant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938481


Locations
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Germany
University Hospital Erlangen
Erlangen, Bayern, Germany, 91054
Japan
Aichi Cancer Centre Hospital
Nagoya-city, Aichi-prefecture, Japan, 464-8681
Fujita Health University
Toyoake, Aichi, Japan, 470-1192
National Canser Centre Hospital East
Chiba-city, Chiba-prefecture, Japan, 277-8577
Teikyo University Chiba Medical Center
Ichihara-shi, Chiba-prefecture, Japan
Keiyukai Sapporo Hospital
Sapporo-city, Hokkaido, Japan, 003-0027
Kurume University School of Medicine
Kurume-city, Hukuoka-prefecture, Japan, 830-0011
Saisei-kai Yokohama-shi Nanbu Hospital
Yokohama-city, Kanagawa-prefecture, Japan, 234-0054
Yokohama-city University
Yokohama-city, Kanagawa-prefecture, Japan, 236-0004
Kanagawa Cancer Centre Hospital
Yokohama-city, Kanagawa-prefecture, Japan, 241-8515
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Takano Hospital
Kumamoto-city, Kumamoto-prefecture, Japan, 862-0924
Mie University Graduate School of Medicine
Tsu-city, Mie-prefecture, Japan, 514-8507
Niigata Cancer Center Hospital
Niigata-city, Niigata-prefecture, Japan
Osaka International Cancer Institute
Osaka-city, Osaka-prefecture, Japan, 537-8511
Saitama Cancer Center
Kitaadachi-gun, Saitama-prefecture, Japan, 362-0806
National Defense Medical College
Tokorozawa-city, Saitama-prefecture, Japan, 359-8513
Shiga University of Medical Science
Otsu-shi, Shiga-prefecture, Japan
Shizuoka Cancer Centre Hospital
Sunto-gun, Shizuoka-prefecture, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya-city, Tochigi-prefecture, Japan
Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
National Cancer Centre Central Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Teikyo University School of Medicine
Itabashi-ku, Tokyo, Japan, 173-8605
Kyorin University School of Medicine
Mitaka-city, Tokyo, Japan, 181-8611
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, Japan, 162-8666
Wakayama Medical University
Wakayama-city, Wakayama-prefecture, Japan
Yamagata Prefectural Central Hospital
Yamagata-city, Yamagata-prefecture, Japan, 990-2292
Korea, Republic of
Yonsei University
Seodaemun-gu, Seoul, Korea, Republic of, 03722
University of Ulsan College of Medicine and Asan Medical Center
Songpa-Gu, Seoul, Korea, Republic of
Lithuania
Klaipeda University hospital
Klaipėda, Lietuva, Lithuania
National Cancer Institute, Lithuania
Vilnius, Lithuania
Russian Federation
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
Taiwan
China Medical University Hospital
Taichung City, Taiwan, 40447
National Taiwan University Hospital
Taipei City, Taiwan
United Kingdom
University of Leeds
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Tokyo Medical and Dental University, Japan
Investigators
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Study Director: Kenichi Sugihara, M.D., Ph.D Tokyo Medical and Dental University, Japan

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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02938481     History of Changes
Other Study ID Numbers: TRICC1410
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
colon cancer, lymph node, extent of bowel resection

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases