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Annual Report 2021

Preface

 The Center for Cancer Genomics and Advanced Therapeutics (C-CAT) was established on June 1, 2018 by 27 staff in the National Cancer Center to collect and store the genomic as well as clinical information of cancer genome profiling (CGP) tests that are conducted under the Japanese national health insurance system. In fiscal year (FY) 2021, C-CAT had 45 staff, including a Director, Deputy Director and Executive Advisors to the Director, and contains the Section of Cancer Genomics Repository, Section of Genome Analysis Platform, the Section of Genomic Data Management, Section of Knowledge Integration, Section of Data Science Strategy, Section of Information Technology Support, Section of Liaison for Cancer Genomic Medicine Hospitals and Administration Office.

 The brief history of CGM and C-CAT began with a discussion at “The Expert Meeting for Cancer Genomic Medicine Promotion Consortium” in the spring of 2017 at the Ministry of Health, Labour and Welfare (MHLW). The Expert Meeting recommended introducing CGM in Japan in a stepwise fashion, starting with qualified hospitals. MHLW accordingly set 11 Designated Core Hospitals and 100 Cooperative Hospitals for CGM in April 2018. By the end of FY2021, the hospitals for CGM numbered 12 Designated Core Hospitals, 33 Designated Hospitals and 188 Cooperative Hospitals.

 Another important proposal from the Expert Meeting was to build a central datacenter, C-CAT, to aggregate genomic as well as clinical information on the patients who undergo CGP testing. C-CAT also generates a “C-CAT findings” report for each patient to provide information including a list of candidate clinical trials that match the mutations detected by the CGP test.

 The major strategic issues and policies of CGM are discussed by various stakeholders including The Council for Cancer Genomic Medicine Promotion Consortium, while logistics and other necessary coordination are the agenda of The Liaison Council of Cancer Genomic Medicine Institutions.

 It was quite remarkable that CGM was launched so successfully in June 2019, when 2 CGP tests were approved for national health insurance reimbursement, considering the very limited time of preparation, one year from the official establishment of C-CAT in 2018. Further, C-CAT was built with the big futuristic vision of data sharing with the CGM hospitals, other academic institutions and third parties. The data sharing through C-CAT consists of 2 parts, one for clinical purposes among the CGM hospitals, and the other for research and development by a wide variety of researchers including those in the industrial sector. The first, the clinical-purpose data sharing, started in September 2020.

 In FY2021, the sharing of the C-CAT data for research and development, the so-called “secondary usage”, started with the full-blown introduction of web-based interactive data exploration systems and with the “C-CAT Data Utilization Review Board” which reviewed 24 applications from both academic and industrial sectors in FY2021. Another important evolution of CGM in 2021 was the introduction of the first “liquid biopsy”, a CGP test on circulating tumor DNA, into the national health insurance system, which will further increase the patients who will benefit from CGM.

 We are deeply grateful for the invaluable and essential cooperation, support and understanding from the staff in the CGM hospitals, Ministry of Health, Labour and Welfare, National Cancer Center, and last but not least, from all the patients and family members who have participated and agreed to offer their vital genomic and clinical information for the data sharing scheme via C-CAT for both clinical and research purposes.

Hiroyuki Mano, M.D., Ph.D.

Director, Center for Cancer Genomics and Advanced Therapeutics