FY2015 Plans of Activities

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1 FY2015 Plans of Activities Since 1950 RERF has conducted the Life Span Study (LSS), a mortality and cancer-incidence study of a fixed cohort of about 94,000 A-bomb survivors in Hiroshima and Nagasaki and 26,000 not in the cities at the time of the bombs. About one-third were still alive as of the most recent follow-up, and follow-up for mortality and cancer incidence are continuing. The Adult Health Study (AHS) was initiated in 1958 as an LSS subcohort of about 17,000 individuals who were examined clinically with continuing biennial clinical examinations, plus about 1,900 individuals exposed at ages of less than 10 years who were added to the cohort in 2008 and are receiving biennial clinical examinations along with other AHS members. In addition, longitudinal clinical research of A-bomb survivors children (F 1 ) was initiated in November 2010 and is progressing smoothly. A second round of health examinations of the F 1 cohort is essentially complete and a third round has begun. Health examinations on four-year cycles will be continued in the years to come. I. Major Activity Plans 1. Research projects on A-bomb survivors health (1) Radiation research based on the LSS, in utero, and AHS cohorts Radiation and cancer: A number of studies will examine the associations of radiation exposure with cancer risk. They include a variety of collaborations among the various research departments. (1)A Extensive work is underway on a comprehensive analysis to provide an 11-year update (covering 1958 through 2009) of radiation risks for cancer incidence in the LSS, in collaboration with the US National Cancer Institute. The new analyses will have increased emphasis on radiation risks from early-life exposures and at low doses, and in relation to lifestyle factors. Paper submissions are anticipated for all solid cancer and for cancers of selected major sites. (1) The in utero cohort study is the only extant study of disease experience in adulthood following prenatal radiation exposure, a topic of importance since in utero exposures have occurred in many settings and the prenatal period may be a time of high radiation sensitivity. A paper on cancer and noncancer mortality risks for is in preparation and will be submitted for publication. (2) Since the hepatocellular carcinoma (HCC) type of liver cancer is associated radiation exposure, AHS investigators are studying the pathogenesis of it by analyzing markers for chronic inflammation, insulin resistance, and liver fibrosis, and by examining the degree to which the association of radiation and HCC may be mediated by hepatitis-b or hepatitis-c viral infections. These factors may help explain why liver cancer radiation risk seems to be greater in the LSS than in western populations. (2) Breast cancer shows one of the highest radiogenic relative risks of any cancer site, but it is not currently known whether various subtypes differ in their sensitivity to radiation effects. A histological review of cases is being conducted, along with immunohistological A (1) indicates highest priority items; (2) indicates second highest priority items. These reflect a blend of RERF-wide and departmental priorities. 1

2 staining of breast cancer specimens to determine intrinsic subtypes according to estrogen and progesterone receptor (ER/PR) and Her2 status. This review is nearly completed; analyses will be undertaken and a paper submitted. The possibility is being explored that breast cancer radiation effects are mediated through alterations in endogenous sex hormone levels. Analyses are complete and a paper has been submitted to internal review. The LSS tumor incidence data have suggested an association of malignant lymphoma with radiation for men but not for women. However, this needs to be verified, and the histologic subtypes and risk factors that may be associated with this are unknown, so a detailed study incorporating histological review of over 450 cases is being analyzed and will help determine whether there is a genuine association. Radiation and circulatory diseases: We anticipate significant progress for several studies of radiation and circulatory diseases, particularly ones oriented toward elucidating mechanisms of radiation-associated cardiovascular disease (CVD), including: (1) Because associations of radiation exposure with mortality from heart failure, hypertensive heart disease, and valvular heart disease have been reported in the LSS, we are conducting an AHS study to confirm the validity of those findings and to develop mechanistic insights based on echocardiography. (1) A detailed dose-response analysis of mortality risk of various heart disease subtypes through 2008 (a 5-year update) is being undertaken as a collaboration of the Cardiovascular Disease Working Group and the departments of Clinical Studies and Epidemiology. (2) A number of measures relevant to CVD risk from radiation are being studied to assess the roles of various biological pathways and pre-clinical indicators of cardiovascular disease. Examples include: markers of chronic inflammation, insulin resistance or adipocytokines; physiological measurements reflecting atherosis (fatty deposits) or arterial stiffness; visceral fat accumulation and fatty liver disease. (2) Using new diagnostic criteria for chronic kidney disease (CKD) based on measurements of both e-gfr (estimated glomerular filtration rate) and microalbuminuria, we will assess the association between radiation and CKD and the role of CKD in radiation-associated CVD. Little is known about heart arrhythmias in relation to low-to-moderate radiation doses. A study was begun on radiation dose and atrial fibrillation, a common arrhythmia. Radiation and other conditions: Studies are being conducted on diseases or conditions other than cancer or circulatory disease: (1) We are developing a new research plan to examine radiation effects on cataract under the guidance of ophthalmologic experts, with carefully standardized assessments. (2) A new study is beginning to examine the radiation dose response regarding blood glucose and lipid levels and the development of diabetes. Since some prior results regarding diabetes were inconsistent, we will evaluate the associations with a more comprehensive longitudinal study and careful methodology. 2

3 Although early A-bomb data showed that in utero radiation exposure conferred early-life mental retardation and cognitive deficits, nothing is known about in utero or childhood exposures and late-life cognitive deficits or dementia. We are conducting a clinical evaluation of late-life neurocognitive function among such AHS participants, as well as using a structured questionnaire to document neurocognitive-deficit symptoms. The LSS and AHS data have shown that chronic liver disease and liver cirrhosis are related to radiation dose. Radiation exposure may accelerate the severity of liver fibrosis through insulin resistance or inflammation, so an analysis of elastometer measurements of liver stiffness and relevant blood markers is planned among AHS subjects exposed at younger ages. Research support activities: Numerous activities are necessary to provide for future high-quality studies of cancer and other health endpoints: (1) Integrated repositories for RERF biosamples in both Hiroshima and Nagasaki are being developed, including a robotic freezer system. Work is also being conducted on developing a comprehensive biosample database that is effective for both research needs and basic biosample management. (1) A database that indexes RERF specimens of formalin-fixed paraffin-embedded tissues is being developed for future specimen utilization. A system to preserve surgically resected materials from the A-bomb survivors in Hiroshima and Nagasaki areas is being worked out with community and university hospitals. (1) Case collection for the Hiroshima and Nagasaki tumor/tissue registries will be completed through 2013, and abstraction of medical records of recent cases is underway. Data will be linked to the LSS, in utero, and F 1 cohorts. (1) The LSS mortality data will be updated through 2011 and will be linked with other LSS data for future analysis. (1) A new round of clinical examinations of the Adult Health Study (AHS) subjects is underway, including the re-examination of about 1,900 additional younger survivors who were under the age of 10 years at the time of the bombings and the in utero subjects. (1) A third round of clinical examination of the F 1 clinical cohort has begun, and about one-fourth of the study subjects will be examined during FY2015. (2) To permit more efficient data management, various standalone electronic data servers are being consolidated onto virtual servers that simplify and further coordinate data management tasks. (2) Activities for promotion of the health and welfare of study participants (1) The Adult Health Study (AHS) and the F 1 clinical study contribute to the promotion of the health and welfare of the A-bomb survivors and their children through regular health examinations and health consultation via telephone contacts or home visits. At the health examinations, physicians provide guidance for disease prevention to study participants, report examination results to their attending physicians, or refer them to medical institutions when more detailed examination or treatment is necessary. Continued support activities provided on occasions other than such medical examinations include health consultation by public 3

4 health nurses, assistance for the elderly or physically challenged in their hospital visits, advice on application procedures involving government allowances for A-bomb survivors, and provision of information regarding governmental consultation services related to welfare benefits. In addition, educational brochures for health promotion are distributed to study participants on a regular basis. (3) Research on biological mechanisms related to health effects from radiation among A-bomb survivors Several studies are being carried out regarding radiation effects on somatic cells and tissues. (1) To help confirm the A-bomb studies suggesting that circulatory diseases may be caused by radiation at moderate doses, we are conducting a validation of the epidemiologic and clinical findings with an experimental study using strains of rats that are susceptible to hypertension and stroke. After a preliminary study at higher doses, a second study is examining doses down to 0.25 Gy, with endpoints of: early stroke symptoms and mortality, a pathologic analysis of relevant organs/tissues, and biochemical measurements related to CVD risk. (2) To develop a greater mechanistic understanding of the metabolic factors affecting the development of radiation-related stroke, a pilot study is beginning to perform a metabolomic analysis of blood of the stroke-prone rats. The pilot study will seek to detect reliable metabolomic patterns that differentiate irradiated and unirradiated rats. (1) Long-lasting radiation effects upon the human hematopoietic system are undergoing analysis and papers will be submitted. In particular, the production of dendritic cells and T cells by hematopoietic stem cells, which trigger and mount immune defenses respectively, are under study. (2) Based on the hypothesis that radiation accelerates or amplifies the age-related attenuation of immunologic function, measurements have been made of numerous immune-related biomarkers and a multivariate statistical model to assess radiation effects on immunologic status and longitudinal changes is being developed. (1) Somatic mutations/genetic alterations that increase susceptibility to radiation-induced thyroid cancer are of great interest because thyroid cancer has been the key disease risk for both Chernobyl and Fukushima. Knowledge of such alterations also can improve our understanding of radiation-induced carcinogenesis. Therefore, a genomic study of papillary adenocarcinoma of the thyroid is being planned in collaboration with the US National Cancer Institute and RIKEN of Japan. (2) We found that a fraction of radiation-associated papillary thyroid cancers (PTCs) without RET/PTC gene rearrangements had ALK gene rearrangements. A study to verify the biological significance of rearranged ALK in radiation thyroid carcinogenesis will be conducted with conditional transgenic mice. (2) Not all the damage from radiation that promotes cancer or other diseases is due to DNA alterations, so we are planning a study of DNA methylation using microarrays. This pilot study will lead to studies of epigenetic alterations associated with irradiation in A-bomb survivors. 4

5 Conduct a genome-wide study of gene expression: a bioinformatics pipeline and analysis are being developed in a new pilot study of genome-wide gene expression using RNA sequencing. This pilot study will lead to a larger study of gene expression alterations associated with A-bomb radiation exposure and immune function. Histological analyses of about 200 LSS thymus autopsy cases will be completed to evaluate the hypothesis that radiation and age alter thymic architecture and immunologic functional capacity. A sophisticated method to assess functional capacity is being developed in collaboration with the University of Georgia. (2) Following fetal irradiation, atomic bomb survivors or mice do not show persistent dose related chromosome aberrations while cells from epithelial tissues such as mammary or thyroid tissues do. These studies have suggested an important role for the tissue niche in the persistence or elimination of radiation-damaged stem cells. These studies have important implications for radiation associated risks following irradiation in utero as well as postnatal radiation exposure. Studies of genes related to immunologic function and DNA repair are being conducted to explore the connections between radiation and cancer or other diseases. These include studies of cancers in relation to radiation and genetic variation related to double-strand-break DNA repair, immunocompetence, and somatic gene mutability. 2. Research projects on the health of A-bomb survivors children (F 1 ) (1) F 1 mortality study and F 1 clinical study (1) Since the F 1 epidemiologic cohort of 77,000 is still young and is only beginning to experience the diseases of mid- and late-life, a continued follow-up for 30 or more years is anticipated. A paper updating the mortality risk for an additional 10 years will be submitted, and an updated analysis of cancer incidence will be initiated. (1) We will continue data cleaning and preliminary tabulations of multifactorial disease outcomes among the F 1 offspring of A-bomb survivors. A statistical analysis plan will be developed for the second round of clinical examinations. (2) Activities for promotion of health and welfare of F 1 study participants These activities are similar to the ones outlined for AHS study participants in Section 1.(2). (3) Research on biological mechanisms related to the health of A-bomb survivors children FY2015 Plans (1) We will complete an initial DNA whole exome sequencing (WES) study to detect de novo mutations. We anticipate a future WES study of the offspring of A-bomb survivors. (1) A-bomb genetic CGH study using a high density array of probes (1.4 million probes per individual) to detect genomic de novo deletions or duplications. The study is comparing the frequency of germline mutations in F 1 subjects from highly-exposed and unexposed parents. The CGH analyses are expected to be completed and a paper submitted. 5

6 (2) We developed a new genetically-modified mouse model with which we can detect in situ germ-cell mutations through expression of a mutant fluorescent protein (green fluorescent protein, GFP). Work is beginning on producing a GFP construct that can be used with a variety of genes, so that mutated tumor oncogenes or tumor-suppressor genes can be studied in relation to radiation exposure. A proposal will be submitted for a study of the F 1 offspring of A-bomb survivors using multicolor FISH (Fluorescent In Situ Hybridization) to simultaneously detect chromosomal abnormalities in all chromosomes. The frequencies of chromosome abnormalities among the F 1 offspring of highly-exposed and unexposed parents will be compared. 3. Research to elucidate individual radiation doses and the effects from atomic bombs (1) Investigation of conditions required for dose estimates including survivor location, shielding effects and organ dosimetry (1) Modern computational phantoms will be used to improve the accuracy of imputed individual organ doses and provide estimates of doses to additional sites. It may also improve dose estimates for partial body exposures such as those of Nagasaki factory workers who were behind benches or other heavy equipment. We are organizing an expert working group of Japanese and American scientists to develop and apply these improved computational phantoms. (2) Gain further understanding of sources and types of uncertainties in atomic-bomb radiation dosimetry and the impact of uncertainties on risk estimates, and develop ways to take these into account statistically. Several groups of external collaborators are approaching the issues in various ways that include using simulations and biodosimetric information. (2) Medical radiation exposure data from the recent LSS mail survey are being analyzed, to help determine if such exposures are associated with A-bomb doses, thereby potentially causing biases. Preliminary analyses suggest that medical radiation exposures are not a major confounder of A-bomb radiation dose, but in-depth analyses will be undertaken and a paper submitted. We will evaluate the potential impact on the LSS of doses from external exposure due to neutron activation of soil in proximity to the bomb hypocenters. A paper will be prepared after clarifying the available data on early entry into the cities near to the hypocenters. We are exploring new methods to estimate doses for those who currently have unknown doses because of complex shielding configurations. The Genetics Department will refine electron spin resonance (ESR) estimates of gamma-ray doses from tooth enamel using correction factors for survivors exposure postures/orientations, mouth tooth location, and the photon-energy dependence of tooth enamel ESR. (2) Research support systems and statistical methodology needed for risk analyses of atomic-bomb radiation 6

7 (1) The Statistics Department will continue its primary role of providing high-quality statistical consulting and oversight on the research projects conducted at RERF. That will involve design and statistical power considerations and culminate with the analysis and interpretation of the data. (1) In seeking methods for improved risk estimation, we are developing and evaluating a semi-parametric method of risk regression that more appropriately estimates the slope and standard errors of excess relative risk at low doses. We expect to publish a paper on non-parametric smoothing methods for dose-response estimation at low doses in (2) We are continuing to gain expertise in adapting and developing analysis methods for bioinformatics and high-dimensional data, such as DNA or RNA sequence data, transcriptomics, epigenetic data and integral immune-function scores. 4. Project to release research results and to collaborate with other scientific organizations RERF will release research results regarding the association of radiation exposure with the health of A-bomb survivors and their children. In addition, with attention paid to the protection of personal information, the foundation will release to the extent possible the data used in the analysis of published study results to allow for third parties to engage in their own analysis. Efforts also will be made to stimulate research activities through partnerships, collaborations, and other joint projects with domestic and international organizations and researchers working in the field of radiation effects. (1) Collaborative research projects FY2015 Plans i) Epidemiologic study on emergency workers at TEPCO Fukushima #1 Nuclear Power Plant MHLW publicly invited a research plan for epidemiologic study on emergency workers at TEPCO Fukushima #1 Nuclear Power Plant in August 2014 and a proposed plan from RERF was officially adopted in October In FY2014, as a pilot study, an interview and health check-up study is being conducted on about 2,000 subjects who are currently living in Fukushima Prefecture. In the four years starting with FY2015, a full scale study will be launched and conducted to establish a life-long cohort group targeting the entire emergency workers of about 20,000, who have already spread out throughout the entire country. We need to establish over 100 focal study points to keep touch with members of the cohort for life-long span and a coordination office in RERF Hiroshima Laboratory. ii) Research project on radiation-related immunity and aging under contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) To define the effects of ionizing radiation on immunological function and aging and elucidate underlying mechanisms, RERF initiated in September 2009 a five-year collaborative study with four Japanese and five U.S. institutions under a research 7

8 contract with NIAID. This study aims to provide a wealth of fundamental biologic information on the impact of radiation on immunosenescence and other health effects. The contract was extended so that during FY2015, the sixth year of the contract, analyses and papers can be produced. iii) Other ongoing international collaborative research projects Collaboration with the U.S. National Cancer Institute A major updated analysis of cancer incidence in the LSS is being undertaken in relation to this collaboration. Also, site-specific cancer incidence studies (female breast, lymphoid tissue, uterus, soft tissue/bone) are underway. Several collaborative papers will be published during FY2015 from those studies, and research activities and mutual feedback will continue in the future. Collaborative research programs in the areas of radiation epidemiology and statistics to increase opportunities to recruit researchers in epidemiology and biostatistics to work at RERF. Studies are ongoing with Kurume University investigators. iv) Facilitation of international collaborative studies. We currently have collaborative studies with 22 North American institutions, 12 European institutions and five Asian/Australian institutions. All the research departments at RERF are engaged in such studies. We anticipate that additional collaborative studies will be developed during FY2015 and beyond as opportunities, ideas or needs develop. 5. Training programs for domestic and overseas specialists RERF will hold a training seminar for non-epidemiologist radiation researchers to learn the basics of epidemiological research and increase understanding of radiation health risks. In addition, RERF will train persons capable of working in the fields of radiation protection, radiation emergency medical care, and radiobiological research. Activity plans for this fiscal year i) RERF will hold an epidemiological training seminar for radiation biologists in Japan again this year for enhanced understanding of results from epidemiology research on A-bomb survivors. ii) RERF will accept overseas research trainees to support the activities of such organizations as the Hiroshima International Council for Health Care of the Radiation-exposed (HICARE), the Nagasaki Association for Hibakusha s Medical Care (NASHIM), and the Japan International Cooperation Agency (JICA). iii) Besides the above activities, RERF will accept students from domestic and overseas schools/universities for facility tours, and will provide training sessions on the foundation s research activities. iv) RERF will review future directions as to its training activities and, on a trial basis, publicly invite overseas trainees in the International Exchange Research Program for FY Public information programs RERF will provide radiation-related information to the public by explaining radiation and 8

9 its effects in an understandable and easily accessible manner through educational support to classes for the general public and students, public seminars, the Open House event, and the provision of relevant information on the Internet and in the form of pamphlets. We will also respond to questions and inquiries submitted from within Japan and from overseas. Activity plans for this fiscal year i) RERF Open House event RERF will hold its 21 st and 19 th Open House events at the Hiroshima and Nagasaki RERF Laboratories, respectively. The event features various programs, including exhibitions, and lectures, and is scheduled to be held in Hiroshima and Nagasaki on August 5 6 and August 8 9, respectively. As this year marks the 70 th and 40 th anniversaries of the A-bomb exposure events and the establishment of RERF, respectively, appropriate contents will be considered. ii) RERF Public Lecture RERF will hold public lectures to provide the general public with an opportunity to enhance their understanding of the foundation s research and to learn more about radiation s health effects. As this year marks the 70 th and 40 th anniversaries of the A-bomb exposure events and the establishment of RERF, respectively, appropriate contents will be considered. Dates: Hiroshima (undecided); Nagasaki (undecided) iii) Permanent exhibits Our permanent exhibits at the Hiroshima and Nagasaki Laboratories introduce the history of ABCC-RERF, the organization s study/research activities, its domestic and overseas collaborative activities, and contributions RERF has made to society. iv) Updating of public relations materials RERF will update its various public relations materials. v) Enhanced RERF website RERF will provide information on its research activities in a more prompt and readily understandable manner using its public website, by posting short summaries of new papers and other such efforts. The existing Q&A section will be updated appropriately and systematized. Educational web seminars (slides with explanatory audio) for the general public will be added. RERF will continue to post information on its Facebook page. vi) Other public relations activities RERF will actively promote the foundation s important papers to the domestic and overseas media via press releases. RERF will organize annual forums for media representatives in Hiroshima and Nagasaki. RERF will develop a proactive public relations system collaborating with all its professional and general staff in a unified manner. RERF will seek an efficient approach with respect to its facility tours. RERF will consider relaunch of the joint lecture series with Hiroshima Jogakuin University. 9

10 II. Activities necessary for the above projects 1. Implementation of Secretariat reorganization due to continued personnel reduction In addition to continuing negotiations with the RERF Labor Union for a labor-management agreement and following administrative procedures for revising the RERF regulations for the implementation of Secretariat reorganization, future actions include preparatory activities of effecting personnel assignment, including salaries, review-based work transfer, and space allocation. We hope to implement the reorganization within FY Review of recruitment plan for young staff in preparation for the aging of the general staff As of the end of FY2015, the budgeted personnel number will be reduced to 209, from 588 at the time of establishment of RERF in 1975, through the implementation of repeated personnel reduction plans. While the number of employees is expected to continue to decrease, the average age of the general employees is over 50. Therefore, there is an urgent need to recruit young personnel, in preparation for the aging of the general employees, as well as to have a well-balanced age distribution. For these reasons, we will review possible ways to secure openings for new recruitment within the budgeted personnel number, for example, through encouraging early retirement, while at the same time developing a five-year recruitment plan for young personnel. 3. Improvement of the Biosample Center s facilities and systems An ultra-low temperature, automated, sample storage and retrieval system (a robotic biorepository) will be installed in September 2015, and construction work is in progress to lower the floor level and renovate rooms on the first floor of Building G for the installation. The Biosample Center is inventorying approximately 600,000 biosamples currently stored and managed by individual research departments for central management in the robotic biorepository, while the Center also continues to perform its routine work. Given current manpower, the task of inventorying biosamples is not expected to be completed until April 2017 (and possibly later). Therefore, we plan to appoint three more technicians to the Center in FY2015 to facilitate inventorying. We also need to secure a preparation room, a laboratory, an office, and a storage room to expedite inventorying, as well as introduce a new system to handle the two-dimensionally barcoded containers that will be stored in the robotic biorepository. 4. Facility upgrades (1) In Hiroshima, installation of a robotic biorepository system in Room 107 of Building G will entail facility upgrades for the Biosample Center on the first floor of Building G and renovation of the laboratory on the second floor of Building B. The estimated cost is 25,000,000. The cost to convert rooms on the second floors of Buildings G and E to offices for researchers and others is estimated at 20,000,000. In addition, the following work is scheduled, using the FY2014 supplementary budget: 1 Replacement of the high-voltage power-receiving units (6600V) and the electric cables of the low-voltage distribution board in Buildings A and Da. The estimated cost is 168,000,

11 2 Seismic strengthening of Buildings I and J to prevent these old structures from collapsing in the event of a disaster. The estimated cost is 158,000,000. (2) Waterproofing of the roof of the Nagasaki Laboratory, which was carried out 18 years ago in 1997, has passed its service life and will be redone at a cost of about 4,000,000. Because the expense will be equally shared with the Nagasaki Prefectural Education Association, RERF expects to bear approximately 2,000,000 of the cost. At present, the capacity of the fuel tanks is sufficient to operate emergency generators for 24 hours. To reduce risk in the event of a disaster, work will be undertaken to increase the capacity of the fuel tanks so that emergency generators can produce enough power to run the ultra-low temperature freezers for 48 consecutive hours. 5. Establishment and revision of regulations concerning operations The current regulations will continue to be reexamined and revised as necessary in order to maintain the administrative operations as a public interest incorporated foundation. 11

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