Clinical trial NCT01767870: Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Adenoma
Keywords: advanced colorectal adenoma
colonoscopy
sigmoidoscopy
fecal immunochemical test
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 5282
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Advanced colorectal adenoma detection rate between two groups
timeFrame: on 7 days after intervention
Secondary outcomes:
measure: Sensitivity of fecal immunochemical test for advanced colorectal adenoma
timeFrame: on 7days after intervention
measure: Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: Sensitivity of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: positive predictive valueof fecal immunochemical test for advanced colorectal adenoma
timeFrame: on 7days after intervention
measure: specificity of fecal immunochemical test for advanced colorectal adenoma
timeFrame: on 7days after intervention
measure: negative predictive value of fecal immunochemical test for advanced colorectal adenoma
timeFrame: on 7days after intervention
measure: specificity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: positive predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: negative predictive value of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: specificityof fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: positive predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
measure: negative predictive value of fecal immunochemical test with sigmoidoscopy for right advanced colorectal adenoma and right colon cancer
timeFrame: on 7 days after intervention
Other outcomes:
measure: Adenoma detection rate and sessile serrated polyp detection rate
timeFrame: on 7 days after intervention
measure: Missing adenoma rate of sigmoidoscopy
timeFrame: on 7 days after intervention
measure: The characteristic of polyps which would be missed by sigmoidoscopy
timeFrame: on 7 days after intervention
measure: Cut off value of fecal immunochemical test that could have equal detection rate for colorectal cancer with colonoscopy.
timeFrame: on 7 days after intervention
measure: Sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy
timeFrame: on 7 days after intervention
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
name: Hyun-Soo Kim, M.D., ph D.
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
name: Hong Jun Park, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
name: Hwang Choi, M.D., ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
name: Jeong Seon Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea
name: Young Suk Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
name: Young-Eun Joo, M.D., ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
name: Jeong Eun Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea
name: Eun Soo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
name: Seong-Eun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea
name: Dong Il Park, M.D., ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea
name: Jae Myung Cha, M.D., ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
name: Sung Noh Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea
name: Seun-Ja Park, M.D., ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
name: Hyun Gun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Sung Pil Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea
name: Jae Hak Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJM200011303432203.
citation: 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.
citation: 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. doi: 10.1002/cncr.11369.
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.
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.
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.
citation: 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. doi: 10.1056/NEJMoa010328.
citation: 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.