Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial

Gut and Liver 2016년 10권 6호 p.925 ~ p.931

신혜영(Shin Hye-Young) - National Cancer Center National Cancer Control Institute
서미나(Suh Mi-Na) - National Cancer Center National Cancer Control Institute
백형원(Baik Hyung-Won) - National Cancer Center National Cancer Control Institute
최귀선(Choi Kui-Son) - National Cancer Center National Cancer Control Institute
박보영(Park Bo-Young) - National Cancer Center National Cancer Control Institute
전재관(Jun Jae-Kwan) - National Cancer Center National Cancer Control Institute
황상현(Hwang Sang-Hyun) - National Cancer Center Center for Diagnostic Oncology Department of Laboratory Medicine
김병창(Kim Byung-Chang) - National Cancer Center Center for Colorectal Cancer
이찬화(Lee Chan-Wha) - National Cancer Center Hospital Center for Cancer Prevention & Detection
오재환(Oh Jae-Hwan) - National Cancer Center Center for Colorectal Cancer
이유경(Lee You-Kyoung) - Soonchunhyang University College of Medicine Department of Laboratory Medicine and Genetics
한동수(Han Dong-Soo) - Hanyang University Guri Hospital Department of Gastroenterology
이도훈(Lee Do-Hoon) - National Cancer Center Center for Diagnostic Oncology Department of Laboratory Medicine

Abstract

Background/Aims: We are in the process of conducting a randomized trial to determine whether compliance with the fecal immunochemical test (FIT) for colorectal cancer screening differs according to the stool-collection method. This study was an interim analysis of the performance of two stool-collection devices (sampling bottle vs conventional container).

Methods: In total, 1,701 individuals (age range, 50 to 74 years) were randomized into the sampling bottle group (intervention arm) or the conventional container group (control arm). In both groups, we evaluated the FIT positivity rate, the positive predictive value for advanced neoplasia, and the detection rate for advanced neoplasia.

Results: The FIT positivity rates were 4.1% for the sampling bottles and 2.0% for the conventional containers; these values were significantly different. The positive predictive values for advanced neoplasia in the sampling bottles and conventional containers were 11.1% (95% confidence interval [CI], ?3.4 to 25.6) and 12.0% (95% CI, ?0.7 to 24.7), respectively. The detection rates for advanced neoplasia in the sampling bottles and conventional containers were 4.5 per 1,000 persons (95% CI, 2.0 to 11.0) and 2.4 per 1,000 persons (95% CI, 0.0 to 5.0), respectively.

Conclusions: The impact of these findings on FIT screening performance was unclear in this interim analysis. This impact should therefore be evaluated in the final analysis following the final enrollment period.

키워드

Colorectal neoplasms, Early detection of cancer, Screening, Intervention study, Predictive value of tests
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SCI(E) MEDLINE 학술진흥재단(KCI) KoreaMed 
주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
The impact of the findings on FIT screening performance was unclear in this interim analysis.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
KCD코드
ICD 03
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