Yoshio Sakai, Masao Honda, Shigeyuki Matsui, Osamu Komori, Toshinori Murayama, Tadami Fujiwara, Masaaki Mizuno, Yasuhito Imai, Kenichi Yoshimura, Alessandro Nasti, Takashi Wada, Noriho Iida, Masaaki Kitahara, Rika Horii, Tamai Toshikatsu, Masashi Nishikawa, Hirofumi Okafuji, Eishiro Mizukoshi, Tatsuya Yamashita, Taro Yamashita, Kuniaki Arai, Kazuya Kitamura, Kazunori Kawaguchi, Hajime Takatori, Tetsuro Shimakami, Takeshi Terashima, Tomoyuki Hayashi, Kouki Nio, Shuichi Kaneko
Cancer Science 110(4) 1364-1388 2019年3月27日
Pancreatic ductal adenocarcinoma (PDAC) is the most life‐threating disease among all digestive system malignancies. We developed a blood mRNA PDAC screening system using real‐time detection PCR to detect the expression of 56 genes, to discriminate PDAC from noncancer subjects. We undertook a clinical study to assess the performance of the developed system. We collected whole blood RNA from 53 PDAC patients, 102 noncancer subjects, 22 patients with chronic pancreatitis, and 23 patients with intraductal papillary mucinous neoplasms in a per protocol analysis. The sensitivity of the system for PDAC diagnosis was 73.6% (95% confidence interval, 59.7%‐84.7%). The specificity for noncancer volunteers, chronic pancreatitis, and patients with intraductal papillary mucinous neoplasms was 64.7% (54.6%‐73.9%), 63.6% (40.7%‐82.8%), and 47.8% (26.8%‐69.4%), respectively. Importantly, the sensitivity of this system for both stage I and stage II PDAC was 78.6% (57.1%‐100%), suggesting that detection of PDAC by the system is not dependent on the stage of PDAC. These results indicated that the screening system, relying on assessment of changes in mRNA expression in blood cells, is a viable alternative screening strategy for PDAC.