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Background  Aberrant DNA methylation has emerged as a class of promising biomarkers for early colorectal cancer (CRC) detection, but the performance of methylated  C9orf50  and methylated  KCNQ5  in stool DNA has never been evaluated.    Methods  Methylation specific quantitative PCR (qPCR) assays for methylated  C9orf50  and methylated  KCNQ5  were developed. The methylation levels of  C9orf50  and  KCNQ5  in 198 CRC patients, 20 advanced adenoma (AA) patients, 101 small polyp (SP) patients, and 141 no evidence of disease (NED) subjects were analyzed.    Results  The methylation levels of both  KCNQ5  and  C9orf50  genes were significantly higher in CRC and AA groups than those in SP and NED groups, but showed no significant difference among different stages of CRC. The sensitivities of methylated  KCNQ5  and methylated  C9orf50  for CRC detection were 77.3% (95% CI: 70.7–82.8%) and 85.9% (95% CI: 80.0–90.2%) with specificities of 91.5% (95% CI: 85.3–95.3%) and 95.0% (95% CI: 89.7–97.8%), respectively. When  C9orf50  and methylated  KCNQ5  were combined, the clinical performance for CRC detection was similar to that of methylated  C9orf50  alone.    Conclusions  Stool DNA based methylated  C9orf50  test has the potential to become an alternative approach for CRC screening and prevention.

KCNQ5 and C9orf50 Methylation in Stool DNA for Early Detection of Colorectal Cancer