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Gut Liver. 2016 Nov 15;10(6):925-931. doi: 10.5009/gnl15479.

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

Author information

1
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
2
Lung Cancer Clinic, Severance Hospital, Yonsei University Health System, Seoul, Korea.
3
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
4
Center for Colorectal Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
5
Center for Cancer Prevention & Detection, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
6
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
7
Department of Gastroenterology, Hanyang University Guri Hospital, Guri, Korea.

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.

KEYWORDS:

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

PMID:
27282262
PMCID:
PMC5087932
DOI:
10.5009/gnl15479
[Indexed for MEDLINE]
Free PMC Article

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