SOLICITATION NOTICE
H -- Comparison of Sex-Hoormone Levels in Breast Adipose Tissue and Serum Collected in the Polish Cace-Control Study
- Notice Date
- 8/31/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-60170-NV
- Response Due
- 9/14/2006
- Archive Date
- 9/29/2006
- Description
- In accordance with Simplified Acquisition procedures, the National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Hormonal and Reproductive Branch (HRB), plans to procure on a sole source basis, for a Comparison of Sex-Hormone Levels in Breast Adipose Tissue and Serum Collected in the Polish Case-Control Study from the University of Southern California, Keck School of Medicine, Women?s & Children?s Hospital, 1240 N. Mission Road., Room 1M2, Los Angeles, CA 90033. The North American Industry Classification System Code is 541380 and the business size standard is $11M. The Hormonal and Reproductive Branch (HRB) conducts research to understand the role of hormones in causing cancer. Research on the hormonal etiology of breast cancer has been an important long-term focus. Sex-hormones play a critical etiologic role in the development of breast cancer. Limited data suggest that steroid hormone levels in breast tumors, non-neoplastic breast tissue, mammary fat and plasma are discordant. Furthermore, whereas serum hormone levels are higher among pre- as opposed to post-menopausal women, concentrations in breast tissues may be more comparable. Accordingly, we hypothesize that breast tissue levels reflects biosynthesis, catabolism and uptake of circulating hormones within the breast; that concentrations may differ in breast tissue and serum; and that the intra-mammary levels are more tightly linked to cancer risk. Accordingly, understanding intra-mammary hormone metabolism is likely to be important for understanding breast cancer etiology and considering prevention strategies. Our inability to define associations between tissue hormone levels and breast cancer risk is attributable to methodologic problems related to measurement and the lack of properly prepared informative samples. Breast tissue contains varying amounts of epithelium, stroma and fatty tissue, making the content of pulverized specimens difficult to characterize. In addition, cross-reactivity between hormones has been problematic for laboratory assays. Because of its relative cellular homogeneity compared to non-fatty breast tissue, its accessibility, and its recognized importance in hormone production, we propose to measure hormones in mammary adipose tissue obtained during surgical removal of breast cancers. In collaboration with the M. Sklodowska-Curie Memorial Cancer Center and the Institute of Oncology in Warsaw and the Institute of Occupational Medicine in Lodz, the Division of Cancer Epidemiology and Genetics (DCEG) of the NCI has conducted a population-based case-control study in Poland. The study enrolled approximately 2,386 breast cancer cases and 2,502 controls. A wealth of data has been amassed through questionnaire administration, anthropometric measurement, physical activity monitoring, and collection of blood, buccal cell, urine, and tissue specimens, including flash frozen mammary fat, tumor, and non-fatty tumor tissue. An important goal of the Polish study is to use a rich specimen resource to understand the role of hormones in breast cancer. Samples of frozen mammary fat were obtained from a total of 314 women in this study, of whom, 233 (74%) also provided breast tumor specimens and blood. Of these, 166 were postmenopausal at the time of surgery. We propose to measure steroid hormones in blood and mammary fat from 96 postmenopausal breast cancer cases, including 64 diagnosed with ER+/PR+ tumors and 32 with ER-/PR- tumors. In addition we will select bloods from an additional 96 control women, frequency matched to the cases on menopausal status and age within 5 years for steroid hormone assessment. The objective of this study is to measure and compare levels of estrogens and androgens in serum and frozen breast adipose tissue obtained from breast cancer cases participating in the Polish breast cancer case-control study, and to compare these to circulating hormones in cancer free controls. The University of Southern California is uniquely qualified to carry out this effort because they have conducted a proof-of-performance study under a previous contract with NCI to refine the extraction procedures on mammary fat and to assess the reproducibility of hormone measurements on the resulting extracts. This work was performed as part of a non-competitive contract (MQ417988). They are considered a leader in measuring hormones in biological samples and have been performing pioneering work on developing and validating methods for measuring hormones in complex biological specimens such as human tissue. The results of our pilot study are very encouraging, with the laboratory successfully measuring estrone (E1), estradiol (E2), androstenedione (A4) and testosterone (T) in frozen mammary fat tissues. The coefficients of variation (CV) ranged from 5%-17% and intraclass correlation coefficients (ICC) ranged between 80%-94%. This collaboration provides a strong basis for extending this work to serum and breast adipose samples from the Polish study of breast cancer. This important research would use a unique, irreplaceable set of specimens. Accordingly, it is vital to perform this research using validated methods. The University of Southern California has developed such methods and has the necessary staff to perform the very laborious and difficult fat extraction required to perform the fat tissue measurements. To achieve the objectives of this study, the University of Southern California will assess and compare hormone levels in serum and breast fat in samples from breast cancer cases according to age and tumor pathology characteristics, such as histology, grade, tumor size, number of positive nodes and hormone receptor status. They will also assess levels according to expression of numerous hormonal markers previously determined by immunostains performed on tissue microarrays include receptors (estrogen, progesterone, androgen), aromatase, steroid sulfatase, and other markers related to hormone levels or actions. They will also assess and compare serum hormone levels in cases and controls. This will be conducted by (1) Assaying serum for the following hormones: E1, E1 SO4, E2, T, A4 and SHBG. Serum from 96 cases, 96 controls and 20 quality control samples shall be aliquotted, batched and shipped to the contractor; and (2) Performing extraction of frozen mammary fat from 96 cases and 10 quality control samples and measure E2, E1, T and A4 in the resulting extracts. Samples of flash frozen mammary fat will be shipped to the contractor. This is not a solicitation for competitive quotations. However, if any interested party believes it can provide the above services, and has the support of the above listed partners, it may submit a statement of capabilities. The statement of capabilities and any other information must be in writing and must contain sufficient detail to allow NCI to determine if the party can perform the requirement. An original and one copy of the capability statements must be received in the contracting office by 2PM EDT on September 14, 2006. All questions must be in writing and can be faxed to (301) 402-4513 or sent via electronic mail to Debbie Moore at dm170b@nih.gov. It is the vendor?s responsibility to call 301-402-4509 to verify all questions have been received. 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. No collect calls will be accepted. In order to receive an award, contractors must be registered in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA).
- Record
- SN01131083-W 20060902/060831220424 (fbodaily.com)
- Source
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