Effectiveness of Fecal DNA Syndecan-2 Methylation Test in Detecting Colorectal Cancer in High-Risk Population in China

Abstract Purpose: To validate the effectiveness of fecal DNA Syndecan-2 methylation (m SDC2 ) test in the detection of colorectal cancer in high-risk population in China. This may provide evidence-based data of diagnostic or screening for colorectal cancer in China. Methods A high-risk Chinese pilot comprising 1130 individuals aged 40-79 was registered for colorectal cancer (CRC) detection using the fecal m SDC2 test. The sensitivity and specificity to CRC, advanced adenomas (AA), and advanced colorectal neoplasia (ACN) were estimated. High-risk factors for incidence of colorectal lesions were analyzed and then were constructed a logistic regression model to better reflect the efficacy of the fecal m SDC2 test. Results According to established criteria, 1035 high-risk individuals were included for analysis. Among them, 16 CRCs (1.55%), 65 AAs (6.28%), 189 NAAs (18.26%), and 150 polyps (14.49%) were defined by colonoscopy and pathological examination. The sensitivity of m SDC2 test to CRC and AA was 87.50% and 40.00%. The specificities were 95.61% in the others group. The positive predictive value (PPV) of m SDC2 test for CRC, AA, and ACN was 16.09%, 29.89% and 45.98%, respectively. In addition, the negative predictive value (NPV) of m SDC2 test for CRC was 99.79%. The positive of m SDC2 test is a significant risk signal for the occurrence of ACN (P <0.001) after adjusting other high-risk covariates. Conclusion The results of this CRC screening showed that offering a combination of fecal m SDC2 test and colonoscopy may be an active option to early detect malignant lesions of the colorectum in Chinese high-risk population.