Abstract
The main modalities for gastric cancer screening are limited to upper gastrointestinal endoscopy and contrast radiography. The former is invasive, and the latter has high false-negative rates. Thus, alternative diagnostic strategies are required. One solution may be a liquid biopsy. Methylated RUNX3 is a well-known biomarker of gastric cancer but it is very difficult to detect with conventional bisulfite-based methylation assays when only a small amount of serum is available. We developed the combined restriction digital PCR (CORD) assay, a new methylation assay allowing for the counting of as little as one copy of a methylated gene in a small sample of DNA without necessitating DNA bisulfite treatment. We evaluated the sensitivity and specificity of the serum DNA testing of methylated RUNX3 by the CORD assay for the detection of early gastric cancer using 50 patients with early gastric cancer and 61 control individuals. The CORD assay had a sensitivity of 50.0% and a specificity of 80.3% for early gastric cancer. Methylated RUNX3 copies were significantly associated with tumor size, massive submucosal invasion, and lymph-vascular invasion. After the treatment, the median number of methylated RUNX3 copies was significantly decreased. The CORD assay may provide an alternative screening strategy to detect even early-stage gastric cancer.
Highlights
Gastric cancer was the 5th most common malignancy and the 3rd leading cause of cancer mortality worldwide in 2018, and incidence rates were markedly elevated in eastern Asia, including Mongolia, Japan, and the Republic of Korea [1]
As there remains a lack of useful biomarkers for gastric cancer screening, the main modalities for such screening are limited to upper gastrointestinal endoscopy and the contrast radiography of the stomach [5]
An increase in methylated RUNX3 copy numbers was significantly related to tumor size, submucosal invasion, and lymph-vascular invasion (Figure 3a–c), but not to the H. pylori status massive submucosal invasion, and lymph‐vascular invasion (Figure 3a–c), but not to the H
Summary
Gastric cancer was the 5th most common malignancy and the 3rd leading cause of cancer mortality worldwide in 2018, and incidence rates were markedly elevated in eastern Asia, including Mongolia, Japan, and the Republic of Korea [1]. In 2018, the 5-year relative rate of survival in Japan was extremely high (94.9%) for stage I gastric cancer, including early gastric cancer. As there remains a lack of useful biomarkers for gastric cancer screening, the main modalities for such screening are limited to upper gastrointestinal endoscopy and the contrast radiography of the stomach [5] Both modalities have disadvantages: upper gastrointestinal endoscopy is invasive and expensive [5], and the barium contrast radiography of the stomach has low sensitivity in early gastric cancer (about 14%) and a high false-negative rate (about 50%) [6,7]. It is important to develop highly sensitive and specific assays to detect early gastric cancer that are non-invasive, inexpensive, and easy to perform
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