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Multicenter Study
. 2019 Jun;30(6):1061-1072.
doi: 10.1681/ASN.2018121232. Epub 2019 Apr 30.

One-Time Fecal Immunochemical Screening for Advanced Colorectal Neoplasia in Patients with CKD (DETECT Study)

Germaine Wong  1   2   3 , Richard L Hope  4 , Kirsten Howard  5 , Jeremy R Chapman  2 , Antoni Castells  6   7   8 , Simon D Roger  9 , Michael J Bourke  4 , Petra Macaskill  5 , Robin Turner  5   10 , Gabrielle Williams  5   3 , Wai Hon Lim  11 , Charmaine E Lok  11 , Fritz Diekmann  12 , Nicholas B Cross  13   14 , Shaundeep Sen  15 , Richard D M Allen  16 , Steven J Chadban  16   17 , Carol A Pollock  18 , Allison Tong  5   3 , Armando Teixeira-Pinto  5   3 , Jean Y H Yang  19 , Narelle Williams  5   3 , Eric Hoi Kit Au  5   3 , Anh Kieu  5   3 , Laura James  5   3 , Jonathan C Craig  20
Affiliations
Multicenter Study

One-Time Fecal Immunochemical Screening for Advanced Colorectal Neoplasia in Patients with CKD (DETECT Study)

Germaine Wong et al. J Am Soc Nephrol. 2019 Jun.

Abstract

Background: In patients with CKD, the risk of developing colorectal cancer is high and outcomes are poor. Screening using fecal immunochemical testing (FIT) is effective in reducing mortality from colorectal cancer, but performance characteristics of FIT in CKD are unknown.

Methods: To determine the detection rates and performance characteristics of FIT for advanced colorectal neoplasia (ACN) in patients with CKD, we used FIT to prospectively screen patients aged 35-74 years with CKD (stages 3-5 CKD, dialysis, and renal transplant) from 11 sites in Australia, New Zealand, Canada, and Spain. All participants received clinical follow-up at 2 years. We used a two-step reference standard approach to estimate disease status.

Results: Overall, 369 out of 1706 patients who completed FIT (21.6%) tested positive; 323 (87.5%) underwent colonoscopies. A total of 1553 (91.0%) completed follow-up; 82 (4.8%) had died and 71 (4.2%) were lost. The detection rate of ACN using FIT was 6.0% (5.6%, 7.4%, and 5.6% for stages 3-5 CKD, dialysis, and transplant). Sensitivity, specificity, and positive and negative predictive values of FIT for ACN were 0.90, 0.83, 0.30, and 0.99, respectively. Of participants who underwent colonoscopy, five (1.5%) experienced major colonoscopy-related complications, including bowel perforation and major bleeding.

Conclusions: FIT appears to be an accurate screening test for patients with CKD, such that a negative test may rule out the diagnosis of colorectal cancer within 2 years. However, the risk of major complications from work-up colonoscopy are at least ten-fold higher than in the general population.

Keywords: cancer; chronic kidney disease; screening; test performance.

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Figures

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Graphical abstract
Figure 1.
Figure 1.
Study flow.
Figure 2.
Figure 2.
Two-year clinical follow-up.
Figure 3.
Figure 3.
Test performance characteristics of fecal immunochemical test for advanced colorectal neoplasia stratified by CKD stage, age, and medication use. FN, false negative; FP, false positive; NPV, negative predictive value; PPV, positive predictive value; TN, true negative; TP, true positive.
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References

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