The Biostatistics Branch both conducts its own field studies as well as consults and collaborates on field studies lead by other DCEG branches.? ? Field Studies Lead by the Biostatistics Branch? ? Shandong Intervention Trial (446)? In April, 2003, we completed the final endoscopies with gastric biopsies for an 8-year trial to determine if treatment for H. pylori, supplementation with garlic extract, or supplementation with a mixture of vitamins E, C, and selenium can reduce the prevalence of severe precancerous gastric lesions. Review of over 21,000 biopsy specimens were completed November 2004. Papers are underway that will evaluate therapy for H. pylori, including an assessment of re-infection rates, investigate the effect of the 3 treatments on precancerous gastric lesions and gastric cancer, and evaluate the possible role of long-term use of the garlic preparation, and supplementation with vitamins A and E and selenium on levels of cholesterol, LDL, and HDL in a random sample of 408 study participants.? ? Breast Cancer Detection Demonstration Project Follow-up Study (1030)? This study follows about 60,000 women who were former participants in the Breast Cancer Detection Demonstration Project (BCDDP). During the past year the following analyses were underway: 1) menopausal hormone replacement therapy and endometrial cancer risk; 2) risk factors for breast cancer according to ER/PR status; 3) folate and alcohol and breast cancer risk; 4) dairy products and ovarian cancer risk; 5) height, body mass index and breast cancer risk; 6) physical activity and breast cancer risk; 7) risk factors for development of breast cancer among women with breast hyperplasia; 8) dietary pooling project analyses (dietary fiber, fruits and vegetables and risk of breast and colon cancer; dietary intake of carotenoids; vitamins A, C, and E and risk of colon cancer; body mass and risk of colon cancer; smoking and risk of colon cancer; diet and risk of ovarian cancer; fluid intake and risk of renal cancer); 8) risk factors for breast cancer according to histologic type and estrogen/progesterone receptor status.? ? Breast Cancer Serum Bank Study (1100)? The Breast Cancer Serum Bank Study is a case-control study involving patients who provided serum prior to breast biopsy or mastectomy between 1977-1987 in three hospitals in Grand Rapids, Michigan. Two case groups, 185 post-menopausal subjects with localized breast cancer and 186 subjects with epithelial breast hyperplasia, were compared to 159 subjects with non-proliferative breast conditions that have not been associated with increased breast cancer risk. We found positive associations between serum estrogens, but not androgens or SHBG, and risk of breast hyperplasia and cancer.? ? A new analysis is underway to evaluate the contribution of inherited genetic variation to benign pre-malignant breast conditions, and to subsequent breast cancer risk in pre-menopausal women. Variants in genes related to hormone metabolism, cell signaling, cell cycle control and apoptosis will be evaluated.? ? Inflammatory Breast Cancer (IBC) Study (314)? We designed a one-year pilot study to determine the feasibility of conducting a case-control study of inflammatory breast cancer (IBC) in collaboration with the National Cancer Institute-Cairo, Egypt and the Institut Salah Azaiz in Tunis, Tunisia. The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study: 1) identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals; 2) selecting appropriate hospital-based control subjects; 3) collecting frozen pre-treatment tumor tissue; 4) obtaining digital photographs of the breasts of IBC cases; and 5) communicating and working collaboratively with the study hospitals and personnel in Egypt and Tunisia. Case accrual is proceeding.
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