SCRUM-Japan GI-SCREEN: The nationwide cancer genome screening projects for gastrointestinal cancer in Japan

Abstract

Several cancer genome alterations have been identified as important targets for cancer treatment. Example of possible candidates in gastrointestinal (GI) cancer include BRAF mutations in colorectal cancer (CRC) or MET amplification in gastric cancer, for which corresponding targeting agents showed attractive activity in early phase clinical trials. Efficient screening systems for these relatively minor cancer genome alterations are necessary for the successful development of targeted therapies. We initiated a nationwide cancer genome screening project in Japan (GI-SCREEN) in February 2014 to detect rare mutations from CRC (GI-SCREEN 2013-01-CRC). The patient's population will be expanded to non-CRC GI cancer including gastric, esophageal, small-intestinal, appendiceal, anal cancers and neuroendocrine carcinoma (SCRUM-Japan GI-SCREEN 2015-01-Non CRC). The objective of these prospective observational studies is to evaluate the frequency of cancer genome alterations in advanced GI cancers and to facilitate the enrollment of patients in IND registration trials for targeted therapies toward individualized treatment. Tumor samples from surgical or biopsy specimens have been examined by Luminex technology until January 2015. Starting from February 2015, it is amended to analyze more than 140 kinds of alterations in cancer genome, which included mutations, copy number variations, and fusion drivers, using next generation sequencing of the Oncomine Cancer Research Panel (OCP) at a quality-controlled central laboratory. Patient characteristics and treatment outcome are planned to be collected in parallel. The targeted sample size is 2,000 patients with CRC and 1,000 patients with non-CRC.