FITS: Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- Advanced colorectal adenoma detection rate between two groups [on 7 days after intervention]
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 [on 7days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7days after intervention]
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 [on 7days after intervention]
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 [on 7days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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 [on 7 days after intervention]
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. [on 7 days after intervention]
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 [on 7 days after intervention]
We will evaluate sigmoidoscopic findings which could predict colorectal advanced adenomas with equal efficacy with colonoscopy.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Asymptomatic subjects aged 45 - 75 years
-
Subjects who will give the written consent
Exclusion Criteria:
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Subjects with past history of colorectal cancer
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Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC)
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Subjects with familial history of colorectal cancer more than 2 familial member in direct line
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Subjects with inflammatory bowel disease(IBD)
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Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification
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Subjects with past history of colectomy
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Subjects with history of colonoscopy within 5 years
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Subjects with history of sigmoidoscopy within 3 years
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Subjects with history of CT colonoscopy within 10 years
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Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wonju Christian Hospital | Wonju | Korea, Republic of | 220-701 |
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CR312033