Annual Report 2022
preface
The Center for Cancer Genomics and Advanced Therapeutics (C-CAT) was established in the National Cancer Center on June 1, 2018 by 27 staff 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) 2022, C-CAT had 49 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 cancer genomic medicine (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. The MHLW accordingly set 11 Designated Core Hospitals and 100 Cooperative Hospitals for CGM in April 2018. By the end of FY2022, the hospitals for CGM numbered 12 Designated Core Hospitals, 33 Designated Hospitals and 198 Cooperative Hospitals.
Another important proposal from the Expert Meeting was to build a central data center, 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 two 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 two 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 FY2022, the “Guidelines for the Establishment of Cancer Genome Medical Core Hospitals” by the Director of the Health Bureau were revised, and at that time, C-CAT repository data was utilized for analyzing the status of CGM. The C-CAT Data Utilization Review Board has been held seven times in total, and 50 research and development projects were approved including seven applications from the industrial sector. A solicited review article on C-CAT has been published in the official journal of the American Association for Cancer Research, Cancer Discovery, and the Japan’s unique CGM platform has attracted great attention worldwide. FY2022 is the fourth year of CGM in Japan, and the number of the patients who consented and registered their data in the C-CAT repository has already exceeded 50,000, and is increasing at a pace of about 20,000 per year. The major revision was approved for the clinical information to be collected in the C-CAT repository database at the end of FY2022. The revision includes an expansion of CGM to the field of the hematological malignancy, in which an introduction of CGP test is expected in the near future.
In FY2023, the revised list of the clinical information will be implemented sequentially. It is expected that new CGP tests will be covered by the national health insurance and the number of tests will further increase, fueled by the active discussions in various occasions for the evolution of CGM. In addition to responding to them, we plan to launch a cloud-computing system for secondary, research & development use of genome sequencing data such as FASTQ and BAM, which are the basis of the CGP test report.
We are deeply grateful for the invaluable and essential cooperation, support and understanding from the staff in the CGM hospitals, the Ministry of Health, Labour and Welfare, the 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