Abstract
BackgroundEarly detection of colorectal cancer (CRC) and precancerous lesion is vitally important for mitigating CRC morbidity and mortality. Aberrant DNA methylations in certain promoter regions have been identified to be closely associated with CRC development and progression, suggesting their potential as diagnostic biomarkers for early detection. In this study, we evaluated the performance of methylated CLIP4 in stool specimens as a potential biomarker for CRC detection.MethodsA total of 321 subjects out of 365 enrolled participants were included in the final analysis, including 154 CRC patients, 23 advanced adenoma (AA) patients, 49 small polyp (SP) patients, and 95 healthy controls. CLIP4 methylation level was examined by qPCR with bisulfite converted DNA purified from approximately 5 g stool specimen.ResultsMethylated CLIP4 test showed high sensitivities of 78.3% (95% CI: 55.8%–91.7%) and 90.3% (95% CI: 84.2%–94.3%) for detecting AA and CRC, respectively, with a specificity of 88.4% (95% CI: 79.8%–93.8%). CLIP4 methylation level discriminated AA and CRC patients from control subjects with area under the curve values of 0.892 (95% CI: 0.795–0.988) and 0.961 (95% CI: 0.938–0.983). Further analysis indicated no significant difference in sensitivities among different ages, genders, stages, locations, sides, tumor sizes and differentiation statuses.ConclusionsMethylated CLIP4 showed a strong potential as a noninvasive biomarker for early CRC detection.
Highlights
Detection of colorectal cancer (CRC) and precancerous lesion is vitally important for mitigating CRC morbidity and mortality
We evaluated the performance of methylated CLIP4 in stool specimens as a potential biomarker for CRC detection
Methylated CLIP4 showed a strong potential as a noninvasive biomarker for early CRC detection
Summary
Detection of colorectal cancer (CRC) and precancerous lesion is vitally important for mitigating CRC morbidity and mortality. Aberrant DNA methylations in certain promoter regions have been identified to be closely associated with CRC development and progression, suggesting their potential as diagnostic biomarkers for early detection. Significant and sustained declines in both incidence and mortality for adults over 50 years old have occurred in the United States, owing to increased awareness of screening, especially by colonoscopy [3, 4]. For adults over 50 years old in the US, routine fecal occult blood test (FOBT) or fecal immunochemical test (FIT) [5], sigmoidoscopy, colonoscopy, computed tomography colonography or stool DNA (sDNA) test are recommended for CRC screening [3, 4]. A large screening campaign of 182,927 participants with high-risk for CRC from 16 Chinese provinces only increased the compliance rate for colonoscopy to 14.0%. History of FOBT or colonic polyp, family history of CRC and high level of education were found to be associated with the increased participation [10]
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