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

January 10, 2013 updated by: Yonsei University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

5282

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Wonju, Korea, Republic of, 220-701
        • Recruiting
        • Wonju Christian Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hyun-Soo Kim, M.D., ph D.
        • Sub-Investigator:
          • Hong Jun Park, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIT-Sigmoidoscopy
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.
Procedure: FIT-sigmoidoscopy
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
Other Names:
  • sigmoidoscopy
  • FITS
Experimental: Colonoscopy
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.
Procedure: Colonoscopy
Advanced colorectal adenoma detection by colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Advanced colorectal adenoma detection rate between two groups
Time Frame: on 7 days after intervention
We will evaluate the advanced adenoma detection rate on 7 days after sigmoidoscopy or colonoscopy when pathologic diagnosis would be reported.
on 7 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of fecal immunochemical test for advanced colorectal adenoma
Time Frame: on 7days after intervention
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.
on 7days after intervention
Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
positive predictive valueof fecal immunochemical test for advanced colorectal adenoma
Time Frame: on 7days after intervention
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.
on 7days after intervention
specificity of fecal immunochemical test for advanced colorectal adenoma
Time Frame: on 7days after intervention
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.
on 7days after intervention
negative predictive value of fecal immunochemical test for advanced colorectal adenoma
Time Frame: on 7days after intervention
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.
on 7days after intervention
specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
Time Frame: on 7 days after intervention
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.
on 7 days after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate and sessile serrated polyp detection rate
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
Missing adenoma rate of sigmoidoscopy
Time Frame: on 7 days after intervention
We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported.
on 7 days after intervention
The characteristic of polyps which would be missed by sigmoidoscopy
Time Frame: on 7 days after intervention
We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported.
on 7 days after intervention
Cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy.
Time Frame: on 7 days after intervention
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.
on 7 days after intervention
Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy
Time Frame: on 7 days after intervention
We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.
on 7 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Study Chair: Hyun-Soo Kim, M.D., ph D., Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
  • Study Director: Hong Jun Park, M.D., Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
  • Principal Investigator: Hwang Choi, M.D., ph D., Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
  • Principal Investigator: Jeong Seon Ji, M.D., Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
  • Principal Investigator: Young Suk Cho, M.D., Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea
  • Principal Investigator: Young-Eun Joo, M.D., ph D., Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
  • Principal Investigator: Jeong Eun Shin, M.D., Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
  • Principal Investigator: Eun Soo Kim, M.D., Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea
  • Principal Investigator: Seong-Eun Kim, M.D., Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
  • Principal Investigator: Dong Il Park, M.D., ph D., Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea
  • Principal Investigator: Jae Myung Cha, M.D., ph D., Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea
  • Principal Investigator: Sung Noh Hong, M.D., Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
  • Principal Investigator: Seun-Ja Park, M.D., ph D., Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea
  • Principal Investigator: Hyun Gun Kim, M.D., Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
  • Principal Investigator: Sung Pil Hong, M.D., Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
  • Principal Investigator: Jae Hak Kim, M.D., Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

January 10, 2013

First Posted (Estimate)

January 14, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 10, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR312033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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