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Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (FITS)

Primary Purpose

Colorectal Adenoma

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FIT-sigmoidoscopy
Colonoscopy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Adenoma focused on measuring advanced colorectal adenoma, colonoscopy, sigmoidoscopy, fecal immunochemical test

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asymptomatic subjects aged 45 - 75 years
  • Subjects who will give the written consent

Exclusion Criteria:

  • Subjects with past history of colorectal cancer
  • Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
  • Subjects with familial history of colorectal cancer more than 2 familial member in direct line
  • Subjects with inflammatory bowel disease(IBD)
  • Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
  • Subjects with past history of colectomy
  • Subjects with history of colonoscopy within 5 years
  • Subjects with history of sigmoidoscopy within 3 years
  • Subjects with history of CT colonoscopy within 10 years
  • Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months

Sites / Locations

  • Wonju Christian HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FIT-Sigmoidoscopy

Colonoscopy

Arm Description

This arm (FIT-Sigmoidoscopy) will take fecal immunochemical test (FIT) followed by sigmoidoscopy for evaluation of advanced colorectal adenoma detection rate. Immediately after sigmoidoscopy, a total colonoscopy will be performed as a standard method for advanced colorectal adenoma detection.

This arm (Colonoscopy) will take a total colonoscopy as a control group that will represent the efficacy of colonoscopy for advanced colorectal adenoma detection rate.

Outcomes

Primary Outcome Measures

Advanced colorectal adenoma detection rate between two groups
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.

Secondary Outcome Measures

Sensitivity of fecal immunochemical test for advanced colorectal adenoma
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
positive predictive valueof fecal immunochemical test for advanced colorectal adenoma
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
specificity of fecal immunochemical test for advanced colorectal adenoma
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
negative predictive value of fecal immunochemical test for advanced colorectal adenoma
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.

Full Information

First Posted
December 19, 2012
Last Updated
January 10, 2013
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01767870
Brief Title
Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
Acronym
FITS
Official Title
Efficacy and Cost-effectiveness of Colonoscopy vs. Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia (eCOLO-FITS): A Randomized Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and cost-effectiveness of fecal immunochemical test combined with sigmoidoscopy (FITS) for the detection of advanced colorectal neoplasia compared to colonoscopy.
Detailed Description
The investigators will evaluate the efficacy of FITS for the detection of advanced colorectal neoplasia compared to colonoscopy. This study was designed as multicenter randomized interventional study. The expected period are 36months. A total 13 tertiary hospitals will participate in the study. Subjects will be randomly allocated to FITS group and colonoscopy group. Subjects who undergo FITS will be performed by following colonoscopy to confirm the efficacy of FITS. In colonoscopy group, subjects as a control group would be performed colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma
Keywords
advanced colorectal adenoma, colonoscopy, sigmoidoscopy, fecal immunochemical test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FIT-Sigmoidoscopy
Arm Type
Experimental
Arm Description
This arm (FIT-Sigmoidoscopy) will take fecal immunochemical test (FIT) followed by sigmoidoscopy for evaluation of advanced colorectal adenoma detection rate. Immediately after sigmoidoscopy, a total colonoscopy will be performed as a standard method for advanced colorectal adenoma detection.
Arm Title
Colonoscopy
Arm Type
Experimental
Arm Description
This arm (Colonoscopy) will take a total colonoscopy as a control group that will represent the efficacy of colonoscopy for advanced colorectal adenoma detection rate.
Intervention Type
Procedure
Intervention Name(s)
FIT-sigmoidoscopy
Other Intervention Name(s)
FITS, sigmoidoscopy
Intervention Description
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Advanced colorectal adenoma detection by colonoscopy
Primary Outcome Measure Information:
Title
Advanced colorectal adenoma detection rate between two groups
Description
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Secondary Outcome Measure Information:
Title
Sensitivity of fecal immunochemical test for advanced colorectal adenoma
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
Time Frame
on 7days after intervention
Title
Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
positive predictive valueof fecal immunochemical test for advanced colorectal adenoma
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
Time Frame
on 7days after intervention
Title
specificity of fecal immunochemical test for advanced colorectal adenoma
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
Time Frame
on 7days after intervention
Title
negative predictive value of fecal immunochemical test for advanced colorectal adenoma
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test for advanced colorectal adenoma on 7days after intervention when pathologic diagnosis would be reported.
Time Frame
on 7days after intervention
Title
specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Description
We will calculate Sensitivity, specificity, positive predictive value and negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer on 7days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Other Pre-specified Outcome Measures:
Title
Adenoma detection rate and sessile serrated polyp detection rate
Description
We will evaluate adenoma detection rate and sessile serrated polyp detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
Missing adenoma rate of sigmoidoscopy
Description
We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
The characteristic of polyps which would be missed by sigmoidoscopy
Description
We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
Cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy.
Description
We will evaluate the cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy on 7 days after colonoscopy when pathologic diagnosis would be reported.
Time Frame
on 7 days after intervention
Title
Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy
Description
We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.
Time Frame
on 7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Asymptomatic subjects aged 45 - 75 years Subjects who will give the written consent Exclusion Criteria: Subjects with past history of colorectal cancer Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC) Subjects with familial history of colorectal cancer more than 2 familial member in direct line Subjects with inflammatory bowel disease(IBD) Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification Subjects with past history of colectomy Subjects with history of colonoscopy within 5 years Subjects with history of sigmoidoscopy within 3 years Subjects with history of CT colonoscopy within 10 years Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Soo Kim, M.D., ph D.
Phone
+82-33-741-1224
Email
hyskim@yonsei.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Jun Park, M.D.
Phone
+82-33-741-1226
Email
ppakongs@daum.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Soo Kim, M.D., ph D.
Organizational Affiliation
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hong Jun Park, M.D.
Organizational Affiliation
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hwang Choi, M.D., ph D.
Organizational Affiliation
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong Seon Ji, M.D.
Organizational Affiliation
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Suk Cho, M.D.
Organizational Affiliation
Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-Eun Joo, M.D., ph D.
Organizational Affiliation
Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong Eun Shin, M.D.
Organizational Affiliation
Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eun Soo Kim, M.D.
Organizational Affiliation
Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong-Eun Kim, M.D.
Organizational Affiliation
Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong Il Park, M.D., ph D.
Organizational Affiliation
Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Myung Cha, M.D., ph D.
Organizational Affiliation
Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Noh Hong, M.D.
Organizational Affiliation
Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seun-Ja Park, M.D., ph D.
Organizational Affiliation
Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyun Gun Kim, M.D.
Organizational Affiliation
Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Pil Hong, M.D.
Organizational Affiliation
Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Hak Kim, M.D.
Organizational Affiliation
Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Soo Kim, M.D., ph D.
Phone
+82-33-741-1224
Email
hyskim@yonsei.ac.kr
First Name & Middle Initial & Last Name & Degree
Hong Jun Park, M.D.
Phone
+82-33-741-1226
Email
ppakongs@daum.net
First Name & Middle Initial & Last Name & Degree
Hyun-Soo Kim, M.D., ph D.
First Name & Middle Initial & Last Name & Degree
Hong Jun Park, M.D.

12. IPD Sharing Statement

Citations:
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11096167
Citation
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Results Reference
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Citation
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Citation
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Results Reference
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PubMed Identifier
15700317
Citation
Launoy GD, Bertrand HJ, Berchi C, Talbourdet VY, Guizard AV, Bouvier VM, Caces ER. Evaluation of an immunochemical fecal occult blood test with automated reading in screening for colorectal cancer in a general average-risk population. Int J Cancer. 2005 Jun 20;115(3):493-6. doi: 10.1002/ijc.20921. Erratum In: Int J Cancer. 2005 Oct 10;116(6):1004.
Results Reference
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PubMed Identifier
18838718
Citation
Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):638-58. doi: 10.7326/0003-4819-149-9-200811040-00245. Epub 2008 Oct 6.
Results Reference
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PubMed Identifier
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Citation
Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, Bresalier R, Andriole GL, Buys SS, Crawford ED, Fouad MN, Isaacs C, Johnson CC, Reding DJ, O'Brien B, Carrick DM, Wright P, Riley TL, Purdue MP, Izmirlian G, Kramer BS, Miller AB, Gohagan JK, Prorok PC, Berg CD; PLCO Project Team. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012 Jun 21;366(25):2345-57. doi: 10.1056/NEJMoa1114635. Epub 2012 May 21.
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Citation
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Citation
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Results Reference
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Links:
URL
http://www.ncc.re.kr
Description
We use the web-based e-Case report form (CRF) system for collection of data from different area, named 'eVLEOS' system which servers are located on Korean National Cancer Center

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Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

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