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Distribution of lymph node metastasis and the extent of lymph node dissection in descending colon cancer patients

Status Approved

First Submitted Date

2018/11/09
Registered Date

2019/01/18
Last Updated Date

2018/12/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003437
Unique Protocol ID	CNUHH-2018-115
Public/Brief Title	Lymph node metastasis in descending colon cancer
Scientific Title	Distribution of lymph node metastasis and the extent of lymph node dissection in descending colon cancer patients
Acronym	Dcolon
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUHH-2018-115
Approval Date	2018-08-07
Institutional Review Board Name	Institutional Review Board of Chonnam National University Hwasun Hospital
Institutional Review Board Address	322, Seoyang-ro, Hwasun-eup, Hwasun-gun, Jeollanam-do
Institutional Review Board Telephone	061-379-7598
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Soo Young Lee
Title	Assistant Professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun-gun Jeonnam, 58128, Korea
Contact Person for Public Queries
Name	Soo Young Lee
Title	Assistant Professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun-gun Jeonnam, 58128, Korea
Contact Person for Updating Information
Name	Soo Young Lee
Title	Assistant Professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun-gun Jeonnam, 58128, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-08-08 Actual
Target Number of Participant	118
Primary Completion Date	2018-08-31 , Actual
Study Completion Date	2018-08-31 , Actual
Name of Study	Chonnam National University Hospital Hwasun Hospital
Recruitment Status	Completed
Date of First Enrollment	2018-08-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The optimal extent of lymph node dissection in patients with descending colon cancer is still debatable. We designed this study to evaluate the distribution of lymph node metastasis and the appropriate extent of lymph node dissection in descending colon cancer patients.

Study Summary Information

Lay Summary

The optimal extent of lymph node dissection in patients with descending colon cancer is still debatable. We designed this study to evaluate the distribution of lymph node metastasis and the appropriate extent of lymph node dissection in descending colon cancer patients.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	118
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Descending colon cancer
Cohort/ Group 1	Cohort/Group Description Retrospective clinical data collection of descending colon cancer patients without distant metastasis, who underwent curative resection between January 2004 and December 2014: age, sex, BMI, tumor location, preoperative CEA, ASA score, operative method, laparoscopy, operative time, T stage, N stage, M stage, lymphatic invasion, vascular invasion, perineural invasion, tumor differentiation, tumor size, distribution of lymph node metastasis
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	descending colon cancer patients without distant metastasis, who underwent curative resection between January 2004 and December 2014
Sampling Method	Extracted from clinical database All descending colon cancer patients who underwent curative resection between Jan 2004 and Dec 2014 (nonprobability sampling)
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C18.6)Malignant neoplasm of descending colon colon cancer
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description descending colon cancer patients without distant metastasis, who underwent curative resection between January 2004 and December 2014
Exclusion Criteria	Familial colorectal cancer, Recurrent colorectal cancer
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Disease-free survival
Timepoint	present
Secondary Outcome(s) 1
Outcome	Overall survival
Timepoint	present

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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