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

A -- COLLECTION OF BLOOD AND PROSTATIC TISSUE SAMPLES SOL RFQ-NCI-80229-NV DUE 092398 POC Debbie Moore, Purchasing Agent, 301-402-4509, Todd Cole, Contracting Officer, 301-4024509 The National Cancer Institute (NCI), Environmental Epidemiology Branch, Division of Cancer Epidemiology and Genetics plans to procure the services of the George Washington University, School of Public Health and Health Sciences, 2300 Eye Street, N. W., Washington, D. C. 20037, for a pilot study to collect blood and prostatic tissue from men for future epidemiologic studies. Although compelling evidence from laboratory studies suggests that androgens play a major role in prostate carcinogenesis, epidemiologic studies in humans (almost exclusively serologic studies) have not been able to confirm the hormonal hypothesis. The major limitation in these serologic studies may stem from the difficulty in measuring androgenicity directly at the target site -- - the prostate. If circulating hormones do not reflect intraprostatic hormone levels or androgenicity, it is not clear how results should be interpreted from serum/plasma measurements, and it is unlikely that future serologic studies can clarify further the role of hormones in prostate cancer etiology. To gain further insights and to provide directions for future epidemiologic studies, NCI proposes to have George Washington University (GWU) conduct a pilot study to collect venous blood and prostatic tissue from up to 150 patients undergoing prostatic surgery (radical prostatectomy, cystoprostatectomy, or transurethral resection of the prostate) in order to measure hormone levels (including testosterone, dihydrotestosterone, androstenedione, androstanediol glucuronide, estradiol, estrone, and estrone sulfate) in prostate directly, to correlate them with serum levels and polymorphism of hormone-related genes (including androgen receptor and SRD5A2, the gene encoding 5 alpha-reductase Type II), and to examine factors (such as age, smoking, body size) that might affect serum-tissue correlation. In addition to tissue levels of hormones, the levels of androgen receptor and its associated protein in prostatic tissue to provide a better estimate of total intraprostatic androgenicity will be measured. Using the first 50 subjects, the reproducibility of tissue hormone assays, including the measurement of intraprostatic, intra-person, intra-assay, inter-assay, and inter-laboratory variation will be evaluated. GWU, using its established coordinating network with local hospitals, shall develop specimen processing manuals and subject recruitment forms; identify and screen eligible patients based on appropriate factors (e.g., age, race, hormone treatment prior to prostatectomy); schedule 2-3 specimen collections per patient with urologists and pathologists; and collect fasting blood and fresh prostatic tissue. Collected blood must be delivered to Biotech (an NCI contractor), Rockville, Maryland for processing within 2 hours and collected tissue delivered to the Armed Forces Institute of Pathology, Washington, D. C. within 2 hours for the cutting of frozen sections, and returned to participating hospitals within 24 hours for pathology review. GWU is the only school of Public Health known in the local area with extensive experience in conducting epidemiologic studies and collecting biospecimens, particularly prostatic tissue. They have successfully conducted similar studies in Italy and Africa and possess in-depth knowledge and experience in epidemiologic studies and prostatic tissue especially in the areas of subject recruitment, specimen collection, and specimen processing. Also, GWU in the only known organization that has an extensive network and affiliations with other health organizations and clinics. Therefore, people undergoing prostatectomy can be readily recruited from the D.C. metropolitan area with enough mixture of black and white patients. 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. The organization performing this study must have documented experience in the collection of blood and prostatic tissue and have an established network with health organizations to obtain diverse subjects from a geographical area. 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 Debbie Moore, 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 09/03/98 (W-SN245498). (0246)

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