임상연구정보서비스

Search: Search

Clinical and Biological characteristics of Interval colorectal cancer in Korea : a Prospective Multicenter Cohort

Status Approved

First Submitted Date

2017/12/13
Registered Date

2019/09/10
Last Updated Date

2019/09/10

Move list page

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	KCT0004292
Unique Protocol ID	KYUH 2017-06-007
Public/Brief Title	Clinical and Biological characteristics of Interval colorectal cancer in Korea : a Prospective Multicenter Cohort
Scientific Title	Clinical and Biological characteristics of Interval colorectal cancer in Korea : a Prospective Multicenter Cohort
Acronym
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	KYUH 2017-06-007
Approval Date	2017-09-29
Institutional Review Board Name	Konyang University Hospital Institutional Review Board
Institutional Review Board Address	158 Goanjeo-Dongro Seogu Daejeon
Institutional Review Board Telephone	042-600-9057
Data Monitoring Committee

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	KyuChan Huh
Title	professor
Telephone	+82-42-600-9104
Affiliation	Konyang University Hospital
Address	Konyang university hospital 158 Gwanjeodong-ro seo-gu Deajeon republic of Korea
Contact Person for Public Queries
Name	KyuChan Huh
Title	professor
Telephone	+82-42-600-9104
Affiliation	Konyang University Hospital
Address	Konyang university hospital 158 Gwanjeodong-ro seo-gu Deajeon republic of Korea
Contact Person for Updating Information
Name	KyuChan Huh
Title	professor
Telephone	+82-42-600-9104
Affiliation	Konyang University Hospital
Address	Konyang university hospital 158 Gwanjeodong-ro seo-gu Deajeon republic of 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	Multi-center Number of center : 8
Overall Recruitment Status	Recruiting
Date of First Enrollment	2018-03-20 Actual
Target Number of Participant	50
Primary Completion Date
Study Completion Date
Name of Study	Konyang University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-03-20 ,
Recruitment Status by Participating Study Site 2
Name of Study	Dankook Univeristy Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-10-31 ,
Recruitment Status by Participating Study Site 3
Name of Study	Jeju National University Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-10 ,
Recruitment Status by Participating Study Site 4
Name of Study	Inje University Haeundae Paik Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-10 ,
Recruitment Status by Participating Study Site 5
Name of Study	Pusan National University Yangsan Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-09-10 ,
Recruitment Status by Participating Study Site 6
Name of Study	Keimyung University Dongsan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-05-09 ,
Recruitment Status by Participating Study Site 7
Name of Study	Chungnam National University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-11-20 ,
Recruitment Status by Participating Study Site 8
Name of Study	Kosin University Gospel Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2018-07-25 ,

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	National Research Foundation
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Konyang University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Colonoscopy is currently considered as the gold standard and the most effective screening method, because it enables the detection and removal of precancerous lesions at the same time. However, a number of authors have recently cast doubt on the effectiveness of colonoscopies in reducing the incidence of proximal colon cancer and CRC-related mortality. Since a significant proportion of colorectal neoplasia is missed during colonoscopic examinations, CRC-related mortality decrease only by 37-65%. Furthermore, 5-8% of CRC cases were diagnosed within the recommended surveillance window after the prior colonoscopy. CRCs, diagnosed relatively soon after negative index colonoscopy, are referred to as interval CRCs, which have been lately recognized as an important clinical issue because reducing middle cancer is very important in preventing colorectal cancer through colonoscopy. To reduce the risk of interval CRC, a comprehensive understanding and the improvement of surveillance strategies are indispensable. Compared to sporadic cancer, interval cancer has different clinical and pathological characteristics. Clinically, it occurs more often in women than men, and the location of colon cancer is higher on the right side than on the left side of the colon. Pathologically, the pathogenesis of cancer, rather than through the pathogenesis of adenoma-carcinoma sequence, is shown by methylation of microstellite instability and CpG island methylation Therefore, it is thought that knowing the clinical-pathological characteristics of interval cancer will increase the prevention of colorectal cancer further This study will be undertaken to assess prevalence, clinical characteristic and molecular biology of interval CRC. In addition, the clinico-pathologic features and molecular biologic features between interval CRC and non-interval CRC patients, age- and sex-matched, will also be covered in this study

Study Summary Information

Lay Summary

Colonoscopy is currently considered as the gold standard and the most effective screening method, because it enables the detection and removal of precancerous lesions at the same time. However, a number of authors have recently cast doubt on the effectiveness of colonoscopies in reducing the incidence of proximal colon cancer and CRC-related mortality. 
 Since a significant proportion of colorectal neoplasia is missed during colonoscopic examinations, CRC-related mortality decrease only by 37-65&#37;. Furthermore, 5-8&#37; of CRC cases were diagnosed within the recommended surveillance window after the prior colonoscopy. CRCs, diagnosed relatively soon after negative index colonoscopy, are referred to as interval CRCs, which have been lately recognized as an important clinical issue  because reducing middle cancer is very important in preventing colorectal cancer through colonoscopy. To reduce the risk of interval CRC, a comprehensive understanding and the improvement of surveillance strategies are indispensable. Compared to sporadic cancer, interval cancer has different clinical and pathological characteristics. Clinically, it occurs more often in women than men, and the location of colon cancer is higher on the right side than on the left side of the colon. Pathologically, the pathogenesis of cancer, rather than through the pathogenesis of adenoma-carcinoma sequence, is shown by methylation of microstellite instability and CpG island methylation 
Therefore, it is thought that knowing the clinical-pathological characteristics of interval cancer  will increase the prevention of colorectal cancer further
 This study will be undertaken to assess prevalence, clinical characteristic and molecular biology of interval CRC. In addition, the clinico-pathologic features and molecular biologic features between interval CRC and non-interval CRC patients, age- and sex-matched, will also be covered in this study

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	Prospective
Target Number of Participant	50
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label To evaluate the clinical and pathological chrateristics of Intrtval cancer, Sporadic cancer
Cohort/ Group 1	Cohort/Group Description Investigators will observe interval cancer group and sporadic cancer group separately, and when all target patients of two groups are finally collected, both will be examined for clinical and pathological characteristics
Biospecimen Collection & Archiving	: DNA Collect & Archive: Sample with DNA
Biospecimen Description	Biopsy specimen of cancer tissue

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	The study population is patients who newly will be diagnosed colon cancer in a college hospital participating in the study The patients were between the ages of 19 and 75
Sampling Method	We choose patients who meet the criteria for interval colorectal cancer among colorectal cancer patients
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C19)Malignant neoplasm of rectosigmoid junction colorectal cancer
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~75Year
	Description 1) Newly diagnosed colorectal cancer in the university hospital participating in the study, patients aged 19 and under 75. 2) patient who was undertaken follow up colonoscopywithin 5 years after index colonoscopy 3) patient who agree with particition of this study after listening to the explanation of the study Non-probability sampling method
Exclusion Criteria	1) A history of colectomy for CRC 2) CRCs from inflammatory bowel disease 3) Familial adenomatous polyposis 4) Liver cihrrosis, CHF[NYHA grade III or IV], CRF [Ccr <30ml/min], uncontrolled hypertension, other malignant diseae and immune suppresion 5) porgnant women, lactating women 6)In case cooperation is difficult, such as communication.
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	Bio-Equivalence
Outcome	Clinical and molecular chraateristuc of interval colon cancer (patient information, index colonoscopy result, pathology result, TNM stagingm, molecular biology marke( BRAF, CIMP (CpG island methylation phenotype), MSI, KRAS 변이
Timepoint	2 years after closing to recruit patients
Secondary Outcome(s) 1
Outcome	Difference between aporadic cancr and interval cancer and etiology of interval cancer
Timepoint	2 years after closing to recruit patients

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	Not provided at time of Registration

Move list page Move to top