Abstract Population-based case-control study in Poland to identify occupational and environmental risk factors for breast cancer Beata Pepłońska1, Montserrat Garcia-Closas2, Louise Brinton2, Aaron Blair2, Neonila SzeszeniaDąbrowska1, Jolanta Lissowska3 Department of Occupational and Environmental Epidemiology, Institute of Occupational Medicine, Łódź, Poland 2 Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA 3 Department. of Cancer Epidemiology and Prevention. Cancer Center and M. Sklodowska-Curie Institue of Oncology, Warsaw, Poland 1 Context: Breast cancer is the most common cancer in women in the world. As many as 1,050,346 incident breast cancer cases were identified in 2000 (Globocan, 2000). Age over 50, breast cancer in first degree relatives, high socio-economic status, exposure to ionizing radiation during adolescence, menopausal obesity, late pregnancy, early menarche, and late menopause are among the most important established risk factors. However, according to various authors, as much as 53-75% of breast cancer cases are unexplained by those agents. Both incidence and mortality rates are higher in females in more developed as compared to less developed countries. This observation raises hypotheses regarding the potential etiologic role of occupational and environmental factors. For instance, an increased incidence or risk of death from breast cancer has been observed in some studies among teachers, nurses and physicians, managers, beauticians and hairdressers, chemists, telephone and telegraph operators, and workers in the pharmaceutical and chemical industry. Some epidemiological studies indicate that breast cancer incidence might be related to occupational exposures to electromagnetic fields, ionizing radiation, low physical activity, organic solvents, and selected pesticides. However, given inconsistent study results and methodological weaknesses (imprecise classification of exposure, low response rate, uncontrolled confounding), no definite conclusions can be drawn. Polymorphisms in genes responsible for metabolizing occupational and environmental chemicals could also affect the risk of breast cancer. Objective: To assess occupational and environmental risk factors for breast cancer in a total series of population-based cases and within groups defined by relevant genetic markers. Design, Setting and Participants: A population-based case-control study was started in February 2000 in two areas in Poland (Warsaw and Łódź). Cases consisted of female residents of Warsaw and Łódź aged 20-74 with newly diagnosed breast cancers that were cytologically or histologically confirmed. Controls were randomly selected within five-year age groups using the Polish Electronic System of Population Evidence. Demographic and other risk factor data were collected using a structured questionnaire. Lifetime work histories were collected, including job title, start and stop dates and work activities, exposure to chemicals, and physical activity at work. Medical information for cases was abstracted from medical records. Blood specimens, mouth wash collections, 12-hour urine samples, and anthropometric measurements were obtained from every subject after written informed consent. Paraffin blocks of tissue samples and alcohol preserved tissue samples were also collected. In Warsaw, additional procedures applied: physical activity monitoring, vacuum bag collection, and fresh tissue collection. Quality control of data were verified by re-abstracting data from medical records for 10% of cases and conducting a short telephone re-interview for 10% of the subjects. The records of the Regional Cancer Registry were reviewed to assess the completeness of case ascertainment. Biologic samples were sent to the United States, where a variety of assays for genetic and environmental risk factors will be conducted. Results: After three years of study, 3,042 incident cases have been identified. Approximately 2,379 (81%) cases have agreed to participate and indicated by written consent in which parts of the study they would participate. Lower response rates occurred in controls–70%. Among women who agreed to participate, 83% of the cases and 90% of controls provided a blood sample. Conclusions: This complex study has successfully enrolled a large number of breast cancer cases and controls with high response rates. The availability of detailed exposure information and biological specimens should allow us to evaluate a large number of etiological questions relevant to breast cancer. Ethical Issue: Subjects who participate in the study will not be provided with individual results of the analyses performed. This data has no diagnostic or therapeutic meaning for study participants. This issue was explained to the participants both in the invitation letter and the consent form.