Kazuhiko Uchiyama1, Yuji Naito2,3, Nobuaki Yagi1,4, Katsura Mizushima1, Yasuki Higashimura1, Yasuko Hirai1, Osamu Dohi1, Tetsuya Okayama1, Naohisa Yoshida1, Kazuhiro Katada1, Kazuhiro Kamada1, Osamu Handa1, Takeshi Ishikawa1, Tomohisa Takagi1, Hideyuki Konishi1, Daisuke Nonaka5, Kyoichi Asada5, Lyang-Ja Lee5, Kenji Tanaka5, Yoshiaki Kuriu6, Masayoshi Nakanishi6, Eigo Otsuji6, Yoshito Itoh1. 1. Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, 465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, 602-8566, Japan. 2. Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, 465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, 602-8566, Japan. ynaito@koto.kpu-m.ac.jp. 3. Department of Endoscopy and Ultrasound Medicine, Kyoto Prefectural University of Medicine, 465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, 602-8566, Japan. ynaito@koto.kpu-m.ac.jp. 4. Department of Gastroenterology, Murakami Memorial Hospital, Asahi University, 3-23 Hashimotocho, Gifu, Gifu, 500-8523, Japan. 5. Membrane Protein and Ligand Analysis Center, Protosera Inc., Amagasaki, 660-0083, Japan. 6. Division of Digestive Surgery, Department of Surgery, Kyoto Prefectural University of Medicine, 465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, 602-8566, Japan.
Abstract
BACKGROUND: Colorectal cancer (CRC) is one of the most predominant types of cancer, and it is the fourth most common cause of cancer-related death and it is important to diagnose CRC in early stage to decrease the mortality by CRC. In our previous study, we identified a combination of five peptides as a biomarker candidate to diagnose CRC by BLOTCHIP®-MS analysis using a set of healthy control subjects and CRC patients (stage II-IV). The aim of the present study was to validate the serum biomarker peptides reported in our previous study using a second cohort and to establish their potential usefulness in CRC diagnosis. METHODS: A total of 56 patients with CRC (n = 14 each of stages I-IV), 60 healthy controls, and 60 patients with colonic adenoma were included in this study. The five peptides were extracted and analyzed by selected reaction monitoring using ProtoKey® Colorectal Cancer Risk Test Kit (Protosera, Inc., Amagasaki, Japan). RESULTS: The results clearly showed that the four CRC groups, stages I-IV, could be sufficiently discriminated from the control group and colonic polyp group. This five-peptide set could identify CRC at each stage compared to the control population in this validation cohort, including those with early-stage disease. The AUC values for each stage of CRC compared to the control population were 0.779, 0.946, 0.852, and 0.973 for stages I, II, III, and IV, respectively. CONCLUSIONS: In this case-control validation study, we confirmed high diagnostic performance for CRC using five peptides that were identified in our previous study as serum biomarker candidates for the detection of CRC.
BACKGROUND:Colorectal cancer (CRC) is one of the most predominant types of cancer, and it is the fourth most common cause of cancer-related death and it is important to diagnose CRC in early stage to decrease the mortality by CRC. In our previous study, we identified a combination of five peptides as a biomarker candidate to diagnose CRC by BLOTCHIP®-MS analysis using a set of healthy control subjects and CRC patients (stage II-IV). The aim of the present study was to validate the serum biomarker peptides reported in our previous study using a second cohort and to establish their potential usefulness in CRC diagnosis. METHODS: A total of 56 patients with CRC (n = 14 each of stages I-IV), 60 healthy controls, and 60 patients with colonic adenoma were included in this study. The five peptides were extracted and analyzed by selected reaction monitoring using ProtoKey® Colorectal Cancer Risk Test Kit (Protosera, Inc., Amagasaki, Japan). RESULTS: The results clearly showed that the four CRC groups, stages I-IV, could be sufficiently discriminated from the control group and colonic polyp group. This five-peptide set could identify CRC at each stage compared to the control population in this validation cohort, including those with early-stage disease. The AUC values for each stage of CRC compared to the control population were 0.779, 0.946, 0.852, and 0.973 for stages I, II, III, and IV, respectively. CONCLUSIONS: In this case-control validation study, we confirmed high diagnostic performance for CRC using five peptides that were identified in our previous study as serum biomarker candidates for the detection of CRC.
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