Spots Global Cancer Trial Database for Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
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Trial Identification
Brief Title: 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 ID: NCT01767870
Conditions
Study Description
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
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Wonju Christian Hospital, Wonju, , Korea, Republic of
Contact Details
Name: Hyun-Soo Kim, M.D., ph D.
Affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Role: STUDY_CHAIR
Name: Hong Jun Park, M.D.
Affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
Role: STUDY_DIRECTOR
Name: Hwang Choi, M.D., ph D.
Affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Jeong Seon Ji, M.D.
Affiliation: Department of Internal Medicine, The Catholic University of Korea College of Medicine, Incheon, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Young Suk Cho, M.D.
Affiliation: Department of Internal Medicine, the Catholic University of Korea, Uijeongbu, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Young-Eun Joo, M.D., ph D.
Affiliation: Departments of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Jeong Eun Shin, M.D.
Affiliation: Departments of Internal Medicine, Dankook University College of Medicine, Cheonan, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Eun Soo Kim, M.D.
Affiliation: Departments of Internal Medicine, Kyungpook National University School of Medicine, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Seong-Eun Kim, M.D.
Affiliation: Departments of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Dong Il Park, M.D., ph D.
Affiliation: Departments of Internal Medicine, Sungkyunkwan University College of Medicine, Seoul, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Jae Myung Cha, M.D., ph D.
Affiliation: Departments of Internal Medicine, Kyung Hee University College of Medicine, Hanam, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Sung Noh Hong, M.D.
Affiliation: Departments of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Seun-Ja Park, M.D., ph D.
Affiliation: Departments of Internal Medicine, Kosin University College of Medicine, Busan, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Hyun Gun Kim, M.D.
Affiliation: Departments of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Sung Pil Hong, M.D.
Affiliation: Departments of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Jae Hak Kim, M.D.
Affiliation: Departments of Internal Medicine, Dongguk University Ilsan Hospital, Ilsan, Korea
Role: PRINCIPAL_INVESTIGATOR
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