Annual Report 2017
Preface
The National Cancer Center (NCC) was designated as one of five hubs for the "Early / Exploratory Clinical Trial Hubs Development Project" in Japan by the Ministry of Health, Labour and Welfare in 2011. In 2012, the NCC- Exploratory Oncology Research & Clinical Trial Center (NCC-EPOC), spanning the NCC's Kashiwa and Tsukiji Campuses, was established with the aim to accelerate the early-stage clinical developments and translational research (hereinafter, TR).
The NCC-EPOC supported the TOP-GEAR trials on the Tsukiji Campus, and participated in the construction of the infrastructure of the SCRUM-Japan on the Kashiwa Campus with the aim to advance the cross-sectional TR in the NCC. In the SCRUM-Japan, the EPOC conducted the gene analyses on over 5,000 cases and the construction of the clinical information database throughout approximately 200 hospitals through nationwide. On the Tsukiji Campus, the EPOC supported the construction and operation of the SCI Laboratory that is an in-hospital genetic screening facility at the Department of Pathology and Clinical Laboratories in the NCC Hospital (NCCH). Additionally, on the Kashiwa Campus, the EPOC constructed a pathology laboratory and immunologic monitoring facility as Japan?s first development research facilities with an aim to obtain the ISO 15189.
The individual activity of each group is as follows.
1. The Group for Clinical Research
The Group for Clinical Research has been operating with the goal to plan drug development so as to establish a framework from which clinical development of hopeful drug seeds from not only the NCC but also from academia in Japan and companies can be conducted quickly from their early stages.
Particularly, the objective is to effectively develop an unapproved academic drug seed to a study drug in an investigator initiated trial by intervening in the process from the early stage with envisaging the possible future clinical development. Also, another objective is to carry out investigator-initiated novel proof of concept (POC) and mode of action (MOA) trials using a private business seed based on TR that is conducted along with clinical research.
2. The Group for Translational Research
The Group for Translational Research is jointly operated by both campuses so that TR is effectively facilitated in the NCC as a whole. The Division of Biomarker Discovery develops novel diagnostic measures and biomarkers. Particularly, this division facilitates cooperative research with pharmaceutical companies to establish patients? derived cell lines of cancer characteristics to Asia and to carry out the pre-clinical tests. The Division of Translational Genomics, on the Tsukiji Campus, produced a gene analysis panel (NCCOncopanel) using next-generation sequencer, and has developed a diagnostic method to detect the genetic abnormality in somatic cells that may be the basis on which personalized therapy may be performed based on genomic information. At the Department of Pathology and Clinical Laboratories in the NCCH, the Division of Translational Genomics constructed an SCI Laboratory jointly with Sysmex Corporation. Currently, they are carrying out genetic testing under a quality control met by the TOP-GEAR-2 Tests at the NCCH. The Division Translational Genomics, on the Kashiwa Campus, is operating a data center for the SCRUM-Japan which is a business-academia collaboration established with the aim to activate clinical development of new drugs through the screening of genetic abnormalities in lung cancer and the digestive system carcinoma on a nationwide scale. The Division of Cancer Immunology established a real-time monitoring system which is capable of analyzing changes in the local immune status before and after treatment with anti-cancer reagents including immune check- point inhibitors. The Division of Clinical Pharmacology and Translational Research established standard techniques for mass spectrometric imaging and fluorescence imaging. These techniques were used for the assessment of drug distribution in clinical samples and pharmacodynamics studies in combination with the PDX model with the aim to facilitate TR directed toward personalized medicine.
3. The Group for Innovative Cancer Treatment
The Division of Pathology is facilitating their translational research using human samples fully, based on the comprehension of characteristics of various tumors and what are clinically required for their treatment. The Division of Developmental Therapeutics established the world?s first antibody capable of recognizing only the insoluble fibrin. The antibody was shared with foreign academic facilities to conduct joint research with them. The Division of Cancer Immunotherapy facilitated bridging the basic research for development of novel immunotherapies or prophylaxes and their clinical applications. In the Division of Psycho-Oncology and the Division of Supportive Care Research, the third-term ?basic programs to promote cancer-fighting measures? was formulated. This program is more conscious of the installation of palliative care of cancer and support of survivors. Each division in the Group for Innovative Cancer Treatment has been promoting research and development focusing on the exploration of seeds for drug discovery and development of novel medical treatments. The Department of Pathology and Clinical Laboratories in the NCC Hospital East (NCCHE), on the Kashiwa Campus, was equipped with a system for the immune monitoring to allow the promotion of TR with the immune translational research field.
4. The Group of Innovative Diagnostic and Therapeutic Device
The objective of the Group of Innovative Diagnostic and Therapeutic Devices is to develop new medical devices. The Division of Functional Imaging has been conducting molecular imaging research centered on nuclear medicine, optical imaging and MRIs with the aim to make cancer treatment minimally invasive and optimized. The Division of Radiation Oncology and Particle Therapy commenced the development of physical and clinical infrastructures for a multicenter study on a scanning radiation technique using a pencil beam, line scanning beam irradiation in proton beam therapy and on proton beam therapy. The Division of BNCT Medical Research has been promoting the pre-clinical and clinical studies on hospital installed boron neutron capture therapy (BNCT). The Division of Science and Technology for Endoscopy promoted the development of new endoscopic diagnostic devices including an endoscope capable of measuring oxygen concentration and the introduction of a high-resolution system with the objective to conduct joint research with private companies. The Division of Surgical Technology is developing an infrastructure to support surgical clinical trials and early clinical trials to develop innovative medical devices as a hub for the development of innovative medical devices in the NCCHE.
Atsushi Ochiai, M.D., Ph.D.
Director
Exploratory Oncology Research & Clinical Trial Center