Circulating insulin-like growth factors and lobular involution of the normal breast in Caucasian and African American women

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room1E144, Bethesda, MD 20892 USA Description: The National Cancer Institute (NCI), Division of Cancer and Epidemiology (DCEG) plans to procure on a sole source basis to Sir Mortimer B. Davis Jewish General Hospital at 3755 Cote-Ste-Catherine Road Montreal, Quebec H3T 1E2 Canada for data related to circulating insulin-like growth factors and lobular involution of the normal breast in Caucasian and African American women. This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1) and is exempt from the requirements of FAR part 6. The North American Industry Classification System Code is 541380 and the business size standard is 500 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of performance will be 12 months from award. Greater degrees of terminal duct lobular unit (TDLU) involution have been linked to lower breast cancer risk; however, factors that influence this process are poorly characterized. The purpose of this procurement is to perform assays for insulin-like growth factor (IGF)-1 and IGF binding protein-3 (IGFBP-3) in serum to assess whether circulating IGF-1 and IGFBP-3, markers associated with cancer, are related to levels of TDLU involution of the breast. NCI has been approved to test serum samples in the Susan G. Komen Tissue Bank at the Indiana University Simon Cancer Center (KTB), and will specifically select up to 800 samples among 1938 women subjects whose Hematoxylin and Eosin have been reviewed. NCI has performed morphometric assessment of TDLUs and developed three reproducible quantitative measures that are inversely associated with TDLU involution: TDLU counts per standardized biopsy, median acini counts/TDLU and median TDLU span in order to identify factors associated with TDLU involution in normal breast tissues from the KTB. The women were participants in the KTB repository, and have given consent to participate in research. Blood levels of growth factors have been previously found to be positively related to breast cancer risk and mammographic density, primarily among premenopausal women; and analysis in the BREAST Stamp Project from HREB has shown an association with IGF-1 and IGFBP-3 and higher TDLU counts suggesting, that this may be an important pathway that inhibits TDLU involution. NCI investigators want to replicate this work and enhance the understanding of how IGF's may influence TDLU involution, using the KTB study samples, a unique source of normal breast tissues, risk factor data, and blood from volunteers for research. Epidemiologic factors that lead to increased exposure to growth factors may alter the breast tissue microenvironment, and might lead to both increased epithelial tissue, specifically TDLUs, which might increase cancer risk. The NCI will test whether IGF-1, IGFBP-3, and the ratio of IGF-1/IGFBP-3 are related to morphometric measurement of TDLUs in a diverse population of both Caucasians and African Americans. The Contractor will perform enzyme-linked immunosorbent assays (ELISA) to measure serum levels of IGF-1 and IGFBP-3.The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays on serum collected from ~800 participants in the KTB study in order to assess whether IGF-1, IGFBP-3, and the ratio of IGF-1/IGFBP-3 are related to TDLU involution in both African Americans and Caucasians. In addition, the Contractor will do the following: 1. The NCI will provide the Contractor with ~100 ul of serum from each of ~725 subjects and from each of ~75 masked quality control samples for a total of ~800 samples. The samples will be labeled with subject identification numbers only; patient identifiers will not be supplied. The NCI will ship the samples via Fed Ex frozen on dry ice. The NCI will provide a specimen manifest in the shipment. Upon receipt, the Contractor shall inventory the serum samples in order to confirm that the identification numbers, number of samples, and serum volumes match that in the specimen manifest. The Contractor shall notify the Contracting Officer's Representative (COR) of any discrepancies between the specimen manifest and specimens received within one week of shipment receipt. 2. After receiving the specimens, the Contractor shall store the samples in-house at -70'C until analyzed, with appropriate storage facilities that include sufficient emergency power supplies to prevent the accidental or unintended destruction or thawing of the specimens. 3. The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays on the stored serum samples provided by NCI. The Contractor shall perform IGF-1 and IGFBP-3 ELISA assays in duplicate. The Contractor shall perform all analyses of specimens in the order provided by the NCI COR and specified in the shipment manifest. 4. The Contractor shall perform all assays under conditions of careful quality control (QC), following the Contractor's usual laboratory quality control procedures and providing all IGF-1 and IGFBP-3 internal quality control results to the NCI COR. 5. The Contractor shall notify the NCI COR within three days of the occurrence of any unusual problems that might affect or delay the completion of this project, such as failure of analytic or quality control procedures, breakdown of instrumentation and equipment, or changes in laboratory personnel. 6. The Contractor shall provide the IGF-1, IGFBP-3, and QC results (i.e. IGF-1 and IGFBP-3 results for serum from controls run with study samples) for each serum sample within an Excel spreadsheet within the period of the contract. 7. Upon completion of the assays, the Contractor shall return any unused frozen serum samples in their original tubes to an NCI bio specimen repository designated by the COR. 8. The Contractor shall collaborate with NCI on data interpretation, analysis, and manuscript preparation. The requested scope of this work can best be completed by Sir Mortimer B. Davis Jewish General Hospital The hospital has extensive experience in measuring circulating IGF-1 and IGFBP-3 and the laboratory is renowned for its high quality of biomarker data, particularly for high quality insulin-like growth factor measurements, with previously reported intra- and inter-batch coefficients of variation on the order of ~10% for IGF-1 and IGFBP-3 assays. Sir Mortimer B. Davis Jewish General Hospital is the only known contractor to NCI that can perform the required tasks. This is not a solicitation for competitive quotations. However, if any interested party, especially a small business, believes they can meet the above requirement, they may submit a statement of capabilities and or quote. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on September 5, 2014. Electronic capability statements will be accepted (i.e. email or fax). An original and one copy must be sent to the NCI Office of Acquisitions at the address stated above. All questions must be in writing and can be faxed to (240) -276-5401 or emailed to Tiffany Kittrell, Contract Specialist, at Tiffany.kittrell@nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) www.sam.gov. No collect calls will be accepted. Please reference solicitation number N02CP42626-62 on all correspondence.