Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
NCT ID: NCT01767870
Last Updated: 2013-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
5282 participants
INTERVENTIONAL
2012-08-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
FIT-sigmoidoscopy
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
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.
Colonoscopy
Advanced colorectal adenoma detection by colonoscopy
Interventions
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FIT-sigmoidoscopy
Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
Colonoscopy
Advanced colorectal adenoma detection by colonoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who will give the written consent
Exclusion Criteria
* 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
45 Years
75 Years
ALL
Yes
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Hyun-Soo Kim, M.D., ph D.
Role: STUDY_CHAIR
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Hong Jun Park, M.D.
Role: STUDY_DIRECTOR
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Hwang Choi, M.D., ph D.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Jeong Seon Ji, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Young Suk Cho, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea
Young-Eun Joo, M.D., ph D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
Jeong Eun Shin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
Eun Soo Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea
Seong-Eun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
Dong Il Park, M.D., ph D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea
Jae Myung Cha, M.D., ph D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea
Sung Noh Hong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
Seun-Ja Park, M.D., ph D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea
Hyun Gun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
Sung Pil Hong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
Jae Hak Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea
Locations
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Wonju Christian Hospital
Wŏnju, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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. doi: 10.1002/cncr.11369.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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CR312033
Identifier Type: -
Identifier Source: org_study_id
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