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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01767870
First received: December 19, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Adenoma
Procedure: FIT-sigmoidoscopy
Procedure: Colonoscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Advanced colorectal adenoma detection rate between two groups [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Adenoma detection rate and sessile serrated polyp detection rate [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    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.

  • Missing adenoma rate of sigmoidoscopy [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    We will evaluate missing adenoma rate of sigmoidoscopy on 7 dyas after sigmoidoscopy when pathologic diagnosis would be reported.

  • The characteristic of polyps which would be missed by sigmoidoscopy [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    We will evaluated the characteristic of polyps which would be missed by sigmoidoscopy on 7 days after sigmoidoscopy when pathologic diagnosis would be reported.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy [ Time Frame: on 7 days after intervention ] [ Designated as safety issue: No ]
    We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.


Estimated Enrollment: 5282
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • FITS
  • sigmoidoscopy
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767870

Contacts
Contact: Hyun-Soo Kim, M.D., ph D. +82-33-741-1224 hyskim@yonsei.ac.kr
Contact: Hong Jun Park, M.D. +82-33-741-1226 ppakongs@daum.net

Locations
Korea, Republic of
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of, 220-701
Contact: Hyun-Soo Kim, M.D., ph D.    +82-33-741-1224    hyskim@yonsei.ac.kr   
Contact: Hong Jun Park, M.D.    +82-33-741-1226    ppakongs@daum.net   
Principal Investigator: Hyun-Soo Kim, M.D., ph D.         
Sub-Investigator: Hong Jun Park, M.D.         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01767870     History of Changes
Other Study ID Numbers: CR312033
Study First Received: December 19, 2012
Last Updated: January 10, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
advanced colorectal adenoma
colonoscopy
sigmoidoscopy
fecal immunochemical test

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 27, 2014