Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date October 17, 2016
First Posted Date October 19, 2016
Last Update Posted Date April 5, 2019
Actual Study Start Date January 22, 2015
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2016)
Distribution of metastatic LNs [ Time Frame: At the time of patient registry in ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02938481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 17, 2016)
  • Prognostic outcomes according to the length of bowel resection [ Time Frame: 3 years ]
  • Prognostic outcomes according to the central radicality [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
Official Title International Prospective Observational Cohort Study for Optimal Bowel Resection Extent and Central Radicality for Colon Cancer
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
  • Resected surgical specimens to take photographs
  • Lymph nodes retrieved from Resected surgical specimens to categorise
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.
Condition Colon Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 17, 2016)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Japan,   Korea, Republic of,   Lithuania,   Russian Federation,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02938481
Other Study ID Numbers TRICC1410
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study Sponsor Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators Tokyo Medical and Dental University, Japan
Investigators
Study Director: Kenichi Sugihara, M.D., Ph.D Tokyo Medical and Dental University, Japan
PRS Account Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Verification Date April 2019