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Randomized Controlled Trial
. 2009 Apr 7;100(7):1103-10.
doi: 10.1038/sj.bjc.6604961.

Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels

L Hol  1 , J A Wilschut, M van Ballegooijen, A J van Vuuren, H van der Valk, J C I Y Reijerink, A C M van der Togt, E J Kuipers, J D F Habbema, M E van Leerdam
Affiliations
Randomized Controlled Trial

Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels

L Hol et al. Br J Cancer. .

Abstract

Immunochemical faecal occult blood testing (FIT) provides quantitative test results, which allows optimisation of the cut-off value for follow-up colonoscopy. We conducted a randomised population-based trial to determine test characteristics of FIT (OC-Sensor micro, Eiken, Japan) screening at different cut-off levels and compare these with guaiac-based faecal occult blood test (gFOBT) screening in an average risk population. A representative sample of the Dutch population (n=10 011), aged 50-74 years, was 1 : 1 randomised before invitation to gFOBT and FIT screening. Colonoscopy was offered to screenees with a positive gFOBT or FIT (cut-off 50 ng haemoglobin/ml). When varying the cut-off level between 50 and 200 ng ml(-1), the positivity rate of FIT ranged between 8.1% (95% CI: 7.2-9.1%) and 3.5% (95% CI: 2.9-4.2%), the detection rate of advanced neoplasia ranged between 3.2% (95% CI: 2.6-3.9%) and 2.1% (95% CI: 1.6-2.6%), and the specificity ranged between 95.5% (95% CI: 94.5-96.3%) and 98.8% (95% CI: 98.4-99.0%). At a cut-off value of 75 ng ml(-1), the detection rate was two times higher than with gFOBT screening (gFOBT: 1.2%; FIT: 2.5%; P<0.001), whereas the number needed to scope (NNscope) to find one screenee with advanced neoplasia was similar (2.2 vs 1.9; P=0.69). Immunochemical faecal occult blood testing is considerably more effective than gFOBT screening within the range of tested cut-off values. From our experience, a cut-off value of 75 ng ml(-1) provided an adequate positivity rate and an acceptable trade-off between detection rate and NNscope.

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Figures

Figure 1
Figure 1
Trial profile. gFOBT: guaiac-based faecal occult blood test; FIT: immunochemical faecal occult blood test; TC: total colonoscopy.
Figure 2
Figure 2
Positivity rate of gFOBT and FIT at different cut-offs in men and women aged 50–59 and 60–74 years.
Figure 3
Figure 3
Numbers needed to scope to find one screenee with an advanced neoplasia in men and women at different cut-off values.
See this image and copyright information in PMC

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