Efficacy Combined Fecal Immunochemical Test-Sigmoidoscopy for the Detection of Advanced Colorectal Neoplasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Colorectal Adenoma

Intervention / Treatment
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* Procedure: FIT-sigmoidoscopy
* Procedure: Colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIT-Sigmoidoscopy<br>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<br>* Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy<br>* Other names: sigmoidoscopy;|
| Experimental: Colonoscopy<br>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<br>* Advanced colorectal adenoma detection by colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced colorectal adenoma, colonoscopy, sigmoidoscopy, fecal immunochemical test