SCRUM-Japan, a Nation-Wide Cancer Genome Screening and Patient Registry Program

Next generation sequencing-based cancer genome analysis has been widely performed in basic research as well as clinical trials. Datasets with comprehensive genome data with limited retrospective clinical information have been provided by national and international consortia and contributed to exploring cancer-related genome information. RET-fusion in non-small cell lung cancer is one of the most successful stories of identifying druggable targets. To maximize the benefit of these results, it is necessary to prove the clinical usefulness by appropriate clinical trials. Recruitment of the patients stratified with genome biomarkers often becomes a barrier to design and implement the proper trials. Nation-wide prospective screening programs have been launched in Japan and other countries. SCRUM-Japan, one of the largest cancer genome screening programs, was established in 2015. We have accumulated genome and clinical information of more than 4,800 cases of lung and gastrointestinal cancers. SCRUM-Japan prioritizes several criteria; validation and short turn-around time of the genomic test, validation of clinical information, secure and immediate data-sharing among academic and industrial collaborators. Appropriately controlled clinico-genome data are useful for guiding the patients to clinical trials. In addition, clinical data of the patients who had target genome alteration but did not enter the clinical trial are also useful to obtain the "natural historical control data". SCRUM-Japan is designated as a model disease registry system by AMED and is establishing a new database system producing more reliable and good for regulatory-use datasets.