Abstract
Background Colorectal cancer (CRC) is one of the leading causes of cancer deaths worldwide and in China. Early CRC screening is the best approach to reduce its incidence and mortality rates. The ColoDefense test, a multiplex qPCR assay simultaneously detecting both methylated SEPT9 and SDC2 genes, has demonstrated improved clinical performance on either methylation biomarker alone for CRC screening with both blood and stool samples. Method Leftover blood chemistry test samples from 125 CRC, 35 advanced adenoma, and 35 small polyp patients and 92 healthy control subjects were examined by the ColoDefense test. Among these samples, the levels of three circulating tumor markers, CEA, AFP, and CA19-9, were also measured for 106 CRC, 28 advanced adenoma, and 20 small polyp patients and all control subjects. Results Due to the smaller volume and extended storage in nonfrozen state, the ColoDefense test with these samples exhibited reduced performance for all stages of CRC and advanced adenomas. The performance of CEA, AFP, and CA19-9 and their various combinations was also evaluated for CRC screening to identify the tumor marker combinations with the best performance. When combined with the ColoDefense test, the identified combinations did improve the clinical performance. Conclusion These results suggested a rational path towards developing a CRC screening method that takes advantage of leftover blood chemistry test samples. The successful development of such a method will undoubtedly help promote early CRC screening by increasing its accessibility for the general public.
Highlights
According to the most recent statistics, colorectal cancer (CRC) ranked the third for incidence rate and the second for mortality rate among all cancers worldwide in 2018 [1]
To evaluate the feasibility of using minimal amounts of leftover serum samples from routine blood biochemistry test for Colorectal cancer (CRC) screening by the ColoDefense test and compare its performance for early CRC screening to that of serum tumor markers, such samples were collected from 125 CRC patients at Nanjing Integrated Traditional Chinese and Western Medicine Hospital, including 3 stage 0, 19 stage I, 38 stage II, 28 stage III, and 37 stage IV patients (Table 1)
For early CRC including stage 0 and I cancers, the area under the curve (AUC) value of methylated SDC2 (mSDC2), 0.576, was nearly identical to that of methylated SEPT9 (mSEPT9), 0.580
Summary
According to the most recent statistics, colorectal cancer (CRC) ranked the third for incidence rate and the second for mortality rate among all cancers worldwide in 2018 [1]. CRC screening is the best approach to reduce its incidence and mortality rates. The ColoDefense test, a multiplex qPCR assay simultaneously detecting both methylated SEPT9 and SDC2 genes, has demonstrated improved clinical performance on either methylation biomarker alone for CRC screening with both blood and stool samples. Leftover blood chemistry test samples from 125 CRC, 35 advanced adenoma, and 35 small polyp patients and 92 healthy control subjects were examined by the ColoDefense test. Due to the smaller volume and extended storage in nonfrozen state, the ColoDefense test with these samples exhibited reduced performance for all stages of CRC and advanced adenomas. These results suggested a rational path towards developing a CRC screening method that takes advantage of leftover blood chemistry test samples. The successful development of such a method will undoubtedly help promote early CRC screening by increasing its accessibility for the general public
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
