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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIT-Sigmoidoscopy | Experimental | 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. |
|
| Colonoscopy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FIT-sigmoidoscopy | Procedure | Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Advanced colorectal adenoma detection rate between two groups | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of fecal immunochemical test for advanced colorectal adenoma | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate and sessile serrated polyp detection rate | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun-Soo Kim, M.D., ph D. | Contact | +82-33-741-1224 | hyskim@yonsei.ac.kr | |
| Hong Jun Park, M.D. | Contact | +82-33-741-1226 | ppakongs@daum.net |
| Name | Affiliation | Role |
|---|---|---|
| Hyun-Soo Kim, M.D., ph D. | Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea | Study Chair |
| Hong Jun Park, M.D. | Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Christian Hospital | Recruiting | Wŏnju | 220-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11096167 | Result | 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. | |
| 19035980 | Result | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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| ID | Term |
|---|---|
| D012812 | Sigmoidoscopy |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| Colonoscopy | Procedure | Advanced colorectal adenoma detection by colonoscopy |
|
| Sensitivity of sigmoidoscopy for right advanced colorectal adenoma and right colon cancer |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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 | 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. | 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 | We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy. | on 7 days after intervention |
| Study Director |
| 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 | Principal Investigator |
| 12733140 | Result | 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. |
| 15700317 | Result | 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. |
| 18838718 | Result | 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. |
| 22612596 | Result | 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. |
| 11529208 | Result | 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. |
| 19426835 | Result | 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. |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |