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

Colorectal Adenoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01767870
Study type Interventional
Source Yonsei University
Contact Hyun-Soo Kim, M.D., ph D.
Phone +82-33-741-1224
Email hyskim@yonsei.ac.kr
Status Recruiting
Phase Phase 4
Start date August 2012
Completion date August 2015
View Details
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