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

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:

MedlinePlus related topics: Benign Tumors Bowel Movement Cancer Colonoscopy

U.S. FDA Resources

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

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:

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, Snover DC, Schuman LM. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000 Nov 30;343(22):1603-7.

Rozen P, Levi Z, Hazazi R, Waked A, Vilkin A, Maoz E, Birkenfeld S, Niv Y. Quantitative colonoscopic evaluation of relative efficiencies of an immunochemical faecal occult blood test and a sensitive guaiac test for detecting significant colorectal neoplasms. Aliment Pharmacol Ther. 2009 Feb 15;29(4):450-7. doi: 10.1111/j.1365-2036.2008.03898.x. Epub 2008 Nov 17.

Wong WM, Lam SK, Cheung KL, Tong TS, Rozen P, Young GP, Chu KW, Ho J, Law WL, Tung HM, Choi HK, Lee YM, Lai KC, Hu WH, Chan CK, Yuen MF, Wong BC. Evaluation of an automated immunochemical fecal occult blood test for colorectal neoplasia detection in a Chinese population. Cancer. 2003 May 15;97(10):2420-4.

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. Erratum in: Int J Cancer. 2005 Oct 10;116(6):1004.

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. Epub 2008 Oct 6. Review. PubMed PMID: 18838718.

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. Epub 2012 May 21.

Lieberman DA, Weiss DG; Veterans Affairs Cooperative Study Group 380. One-time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon. N Engl J Med. 2001 Aug 23;345(8):555-60. Summary for patients in: Gastrointest Endosc. 2002 May;55(6):760-1.

Kato J, Morikawa T, Kuriyama M, Yamaji Y, Wada R, Mitsushima T, Yamamoto K. Combination of sigmoidoscopy and a fecal immunochemical test to detect proximal colon neoplasia. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1341-6. doi: 10.1016/j.cgh.2009.04.025. Epub 2009 May 6.

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 May 16, 2013

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