National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

A -- NUTRITION INTERVENTION TRIALS IN LINXIAN CHINA SOL RFQ80236-NS DUE 092198 POC Patricia Haun (301) 402-4509 The Cancer Prevention Studies Branch (CPSB), Division of Clinical Sciences (DCS), National Cancer Institute (NCI) plans to procure the research services of the Chinese Academy of Medical Sciences, Panjiayuan, Chaoyang District, P.O. Box 2258, Beijing, China 100021. Background Probably the highest worldwide rates of esophageal cancer occur in Linxian, China where cumulative death rates to age 75 for this cancer exceed 20%. Widespread deficiencies of multiple nutrients are considered the most likely cause, but consumption of pickled vegetables, moldy foods and nitrosmines, and physical trauma from silica fragments in ingested millet may also play a role. Given this situation, the primary objective of this project is to determine if supplementation with multiple vitamin-minerals reduces the incidence and mortality of esophageal and/or other cancers, and total mortality. Secondary objectives are to assess supplemental effects on intermediate endpoints in carcinogenesis and to examine new hypotheses relating to the etiology and prevention of upper gastrointestinal cancers. Two double-blind, placebo controlled randomized intervention studies were conducted to evaluate multiple vitamins/minerals in the prevention of esophageal and other cancers a Dysplasia Trial (3,318 people evaluated for six years) and a General Population Trial (29,584 people evaluated over approximately five years and specimens collected). Both trials concluded in 1991 and results showed that the combinations of beta-carotene, vitamin E, and selenium reduced total mortality, total cancer mortality, and stomach cancer incidence and mortality. Results from endoscopic and cytologic examinations suggested that vitamins and minerals may decrease proliferation and enhance cytologic reversion to nondysplasia. Requirement The purpose of this requirement, which is a follow to the two previous studies conducted by the Chinese Academy of Medical Sciences, is to: 1) obtain updated endpoint data on the Nutrition Intervention Trial participants for theperiod June 1998 through May 1999; 2) collect and store all available diagnostic materials for the Nutrition Intervention Trial participants for new cancers diagnosed during the period June 1998 through May 1999; 3) continue storage of all existing blood samples collected during the Nutrition Intervention Trials in freezers at -85 degrees Centigrade, and provide a record of daily freezer and ambient temperatures in the freezer storage room; 4) develop a plan for the collection of an additional blood sample from all trial participants who are still alive. This effort will enable continued study of the trial participants to better understand the etiology of upper gastrointestinal cancer and strategies for prevention. Since the Chinese Academy of Medical Sciences has the rights to the data from the previous studies, strong affiliations with the network of clinics and health care organizations where trial participants receive care, and an intimate knowledge of these particular ongoing studies in Linxian, it is the only known source who can meet the requirements of this follow up study, including locating trial participants who are still alive. If any interested party believes it can perform the above work, it may submit a statement of capabilities. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform this requirement. Capability statements must be received in the contracting office by 3:00 p.m. EST, on September 21, 1998. If you have any questions, please contact Patricia Haun, Purchasing Agent on (301) 402-4509. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Posted 09/04/98 (W-SN246124). (0247)

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