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 2016³â 10±Ç 6È£ p.925 ~ p.931

½ÅÇý¿µ(Shin Hye-Young) - National Cancer Center National Cancer Control Institute
¼­¹Ì³ª(Suh Mi-Na) - National Cancer Center National Cancer Control Institute
¹éÇü¿ø(Baik Hyung-Won) - National Cancer Center National Cancer Control Institute
Ãֱͼ±(Choi Kui-Son) - National Cancer Center National Cancer Control Institute
¹Úº¸¿µ(Park Bo-Young) - National Cancer Center National Cancer Control Institute
ÀüÀç°ü(Jun Jae-Kwan) - National Cancer Center National Cancer Control Institute
Ȳ»óÇö(Hwang Sang-Hyun) - National Cancer Center Center for Diagnostic Oncology Department of Laboratory Medicine
±èº´Ã¢(Kim Byung-Chang) - National Cancer Center Center for Colorectal Cancer
ÀÌÂùÈ­(Lee Chan-Wha) - National Cancer Center Hospital Center for Cancer Prevention & Detection
¿ÀÀçȯ(Oh Jae-Hwan) - National Cancer Center Center for Colorectal Cancer
ÀÌÀ¯°æ(Lee You-Kyoung) - Soonchunhyang University College of Medicine Department of Laboratory Medicine and Genetics
Çѵ¿¼ö(Han Dong-Soo) - Hanyang University Guri Hospital Department of Gastroenterology
À̵µÈÆ(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.

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Colorectal neoplasms, Early detection of cancer, Screening, Intervention study, Predictive value of tests
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