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

Phase 4

• Conditions: Colorectal Adenoma
• Interventions: Procedure: FIT-sigmoidoscopy; Procedure: Colonoscopy

• Registration Number: NCT01767870
• Lead Sponsor: Yonsei University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-12-19
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-14
• Last Update Posted: 2013-01-14
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5282

Inclusion Criteria

• Asymptomatic subjects aged 45 - 75 years
• Subjects who will give the written consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FIT-Sigmoidoscopy	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.
Colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Wonju Christian Hospital; 🇰🇷 Wonju, Korea, Republic of