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Korean Colonoscopy Screening Project

Status Approved

  • First Submitted Date

    2019/07/12

  • Registered Date

    2019/07/15

  • Last Updated Date

    2020/03/29

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    		 KCT0004142
    Unique Protocol ID 1960600-1
    Public/Brief Title Korean Colonoscopy Screening Project
    Scientific Title Korean Colonoscopy Screening Project
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted approval

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number NCC2019-0162
    Approval Date 2019-07-10
    Institutional Review Board Name National Cancer Center Institutional Review Board
    Institutional Review Board Address 323, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
    Institutional Review Board Telephone 031-920-0425
    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 Mina Suh
    Title Senior Scientist
    Telephone +82-31-920-2911
    Affiliation National Cancer Center
    Address 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
    Contact Person for Public Queries
    Name Bomi Park
    Title Associate Scientist
    Telephone +82-31-920-2925
    Affiliation National Cancer Center
    Address 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
    Contact Person for Updating Information
    Name Jiyoung Yoo
    Title Assistant Scientist
    Telephone +82-31-932-7542
    Affiliation National Cancer Center
    Address 323 Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do

  • 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
    Study Site Multi-center Number of center : 52
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-08-08 Actual
    Target Number of Participant 53280
    Primary Completion Date 2021-11-30 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study National Cancer Center
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-08 ,
    Recruitment Status by Participating Study Site 2
    Name of Study National Health Insurance Service Ilsan Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Grace Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Kim & U Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Gimpo Woori Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Gimpo Best Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Na & Lee Women Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 8
    Name of Study New Korea Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Deun Deun Han Internal Medicine
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 10
    Name of Study Bae Won Yeop Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Samsung Top Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Seoul Sok Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Saint Mary's Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Hepato-Gastroenterology Clinic Center
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 15
    Name of Study Yonsei Madu Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 16
    Name of Study Yonsei bom Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 17
    Name of Study Yonsei el Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 18
    Name of Study Yeonsei Chungdam Proctology Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 19
    Name of Study Yeonsei Hangmac Surgery Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 20
    Name of Study Wicity St, Mary's Will Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 21
    Name of Study Gastroenterology tntn Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 22
    Name of Study Yoomin Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 23
    Name of Study Il-san modeun Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 24
    Name of Study Il-san Gospel Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 25
    Name of Study Jainmedi Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 26
    Name of Study Choeun Mirae Women's OB/GYN Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 27
    Name of Study Jo Hyun Chul Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 28
    Name of Study Jin Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 29
    Name of Study Pyunan Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 30
    Name of Study Hanbit Radiology Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 31
    Name of Study Haeng Shin Yonsei Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 32
    Name of Study Hyun Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 33
    Name of Study Health Dream Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 34
    Name of Study Good Morning Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 35
    Name of Study Yonsei Smile Internal Medicine Clinic
    Recruitment Status Recruiting
    Date of First Enrollment 2019-08-12 ,
    Recruitment Status by Participating Study Site 36
    Name of Study Gyeonggi Provincial Medical Center Paju Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 37
    Name of Study Gimpo Dajoeun Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 38
    Name of Study Dr Leaders Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 39
    Name of Study Medi Yin Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 40
    Name of Study Seoul W Internal Medicine ILSAN
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 41
    Name of Study Seoul Samsung Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 42
    Name of Study Seoul365 Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 43
    Name of Study Seoul Goyang Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 44
    Name of Study Yonsei Mitum Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 45
    Name of Study Yonhap Hangang Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 46
    Name of Study Paju Hepato-Gastroenterology Clinic Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 47
    Name of Study Unjeong Samsung Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 48
    Name of Study The Mirae Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 49
    Name of Study Hansarang General Surgery Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 50
    Name of Study Heryoojae Women`s Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 51
    Name of Study Hwang Hyo Joo Internal Medicine Clinic
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,
    Recruitment Status by Participating Study Site 52
    Name of Study HisMedi Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-05-01 ,

  • 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 Ministry of Health & Welfare
    Organization Type Government
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name National Cancer Center
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    1. Aim of the study
▪ Primary aim of the study: To evaluate the effect of colonoscopy in the general population and to examine the feasibility of colonoscopy as a primary screening modality for the national colorectal cancer screening program in Korea

▪Secondary aim of the study: To evaluate the risk (side effect) and acceptability (satisfaction of the examination) of colonoscopy in the general population

2. Background
Korea currently provides fecal occult blood test as a national colon cancer screening program, but the screening rate for colorectal cancer is lower than other cancer types. This is probably because of the inconvenience and low sensitivity of the fecal occult blood test and increased demand for colonoscopy. The necessity of introducing colonoscopy as a primary national colorectal cancer screening tool has been continuously raised.

3. Outline
▪ Study Subjects: Male and female aged 50-74 years 
▪ Scale: test group: total of 26,640 (4,000 in 2019) / Control group: total of 26,640 (Selected from the national colorectal cancer screening database with 1:1 paired matching with the test group) 
▪ Participation period: July 1, 2019. ~ November 30, 2021
▪ Data collection period: July 1, 2019. ~ November 30, 2021
▪ Total expected research period: IRB approval date ~ December 31, 2021

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Screening
    Phase Not applicable
    Intervention Model Others (We will recruit test group who will receive colonosccopy, and control group will be selected from the national colorectal cancer screening database (secondary data).)
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type /Procedure/Surgery  
    Intervention Description 
    ▪ All participants in the test group will be screened for colorectal cancer using a colonoscopy. Within 7 days and 3 weeks after colonoscopy, telephone survey will be conducted to evaluate the side effect and satisfaction of colonoscopy.
▪ Control group will be selected from the national colon cancer screening database (secondary data). Data of adults who participated in the national colon cancer screening program and screened for colorectal cancer with fecal occult blood test will be included in the control group.
    Number of Arms 2
    Arm 1

    Arm Label

    Participants in Colonoscopy Screening Project

    Target Number of Participant

    26640

    Arm Type

    Experimental

    Arm Description

    All participants in the test group will be screened for colorectal cancer using a colonoscopy. A telephone survey (within 7 days after the test, and within 3 weeks after the test) will be conducted to evaluate the side effect and satisfaction of the colonoscopy screening.
    Arm 2

    Arm Label

    The National Colorectal Cancer Screening Program(fecal occult blood test, FOBT) Database

    Target Number of Participant

    26640

    Arm Type

    Active comparator

    Arm Description

    Control group will be selected from the national colon cancer screening database (secondary data). Data of adults who participated in the national colon cancer screening program and screened for colorectal cancer with fecal occult blood test will be included in the control group.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C18.9)Malignant neoplasm of colon, unspecified 

    Colorectal Neoplasms
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    50Year~74Year

    Description

    ▪ Test group
① 50-74 years old
② A resident in the pilot study area who is willing to participate voluntarily in the colonoscopy pilot study

▪ Control group
Control group will be selected from the national colon cancer screening database (secondary data). Adults between 50 and 74 years who participated in the national colon cancer screening program and screened for colorectal cancer with fecal occult blood test will be included in the control group with 1:1 paired matching with the test group.
    Exclusion Criteria 
    ▪ Test group
① People who have been diagnosed and treated or are under treatment for colorectal cancer
② People who had colonoscopy within 5 years (which is the same as the current grace period of the national cancer screening program)

▪ Control group (National Colorectal Cancer Screening database)
① People who have been diagnosed and treated or are under treatment for colorectal cancer
② People who had colonoscopy within 5 years (which is the same as the current grace period of the national cancer screening program)
    Healthy Volunteers

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    Colorectal cancer detection rates
    Timepoint 
    After colonoscopy completion of targeted sample size
    Primary Outcome(s) 2
    Outcome 
    Changes in cancer staging
    Timepoint 
    After colonoscopy completion of targeted sample size
    Secondary Outcome(s) 1
    Outcome 
    Complication incidence of colonoscopy
    Timepoint 
    After colonoscopy completion of targeted sample size
    Secondary Outcome(s) 2
    Outcome 
    Satisfaction with colonoscopy screening
    Timepoint 
    After colonoscopy completion of targeted sample size

  • 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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