Performance of the Fecal Immunochemical Test for Colorectal Cancer Screening Using Different Stool-Collection Devices: Preliminary Results from a Randomized Controlled Trial.
OBJECTIVE
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.
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Hye Young
HY
Shin
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Mina
M
Suh
National Cancer Control Institute, National Cancer Center, Goyang, Korea.|Lung Cancer Clinic, Severance Hospital, Yonsei University Health System, Seoul, Korea.
Hyung Won
HW
Baik
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Kui Son
KS
Choi
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Boyoung
B
Park
National Cancer Control Institute, National Cancer Center, Goyang, Korea.
Jae Kwan
JK
Jun
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
Sang-Hyun
SH
Hwang
Center for Colorectal Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
Byung Chang
BC
Kim
Center for Cancer Prevention & Detection, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
Chan Wha
CW
Lee
Center for Colorectal Cancer, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
Jae Hwan
JH
Oh
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
You Kyoung
YK
Lee
Department of Gastroenterology, Hanyang University Guri Hospital, Guri, Korea.
Dong Soo
DS
Han
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center Hospital, National Cancer Center, Goyang, Korea.
Do-Hoon
DH
Lee
D000368:Aged; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D055088:Early Detection of Cancer / Q000295:instrumentation* / Q000379:methods; D005243:Feces / Q000737:chemistry*; D005260:Female; D006801:Humans; D007120:Immunochemistry; D007159:Immunologic Tests / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008403:Mass Screening / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged; D011237:Predictive Value of Tests
Colorectal neoplasms; Early detection of cancer; Intervention study; Predictive value of tests; Screening