Recruit Breast Cancer Patients and Collect Clinical and Epidemiologic Data and Biospecimens

The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Integrative Tumor Epidemiology Branch (ITEB) plans to procure on a sole source basis services to continue the collection of fresh frozen breast tissues and formalin-fixed paraffin-embedded (FFPE) tissue slides in two hospitals from The Chinese Hospital of Hong Kong, 4/F School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong SAR, China. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System code is 541990 and the business size standard is $15.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a severable firm fixed price type contract. The period of performance will be 12 months after date of award It has been determined there are no opportunities to acquire green products or services for this procurement. Background Although the incidence rate for invasive female breast cancer in Asia is still much lower (3-fold lower) than North America and Europe (Globocan 2012; http://globocan.iarc.fr), rates have been increasing rapidly in many Asian populations. In particular, rates in younger age groups in some Asian populations have approached or even surpassed those of Western women [1]. Westernized lifestyle has been proposed to account for much of the rate increase; however, Asian women have a distinct profile of breast cancer that differs from that seen in Western populations, including earlier age at onset and a higher frequency of more aggressive tumors [2, 3]. In addition, the relationship between breast density, which is a well-known breast cancer risk factor in Western women, and breast cancer risk among Asian women seems to be complex since Asian women in general have denser breasts but have lower overall incidence of breast cancer than Western women [4, 5]. It is possible that a variety of complex factors contribute to these unique features observed among Asian women, including cohort/period effects, distinct age-specific etiology, or tumor biology. Gene expression profiling studies have suggested that breast cancers comprise several biologically and clinically distinct tumor subtypes [6, 7]. Using data from available population-based epidemiologic studies, we have conducted studies associating molecular subtypes with distinct morphologic and etiologic factors [8-10]. Recently, integrated tumor profiling studies using information from somatic mutations, copy number alterations (CNA), DNA methylation, and microRNA profiling have improved molecular classification and refined existing breast cancer subtypes [11, 12]. However, the available data are almost exclusively from studies in Western women. In addition, very few studies have integrated somatic alterations with etiologic factors. The expansion of genomic studies to understudied populations with the integration of etiologic factors will allow the capture of a much wider range of genetic structure and mutagenic exposures, which can be revealed through somatic changes in tumors. This will also have implications for developing targeted prevention strategies, not only for native Asian women but also for Asian Americans, a particularly important target since the Asian American population has grown faster than any other racial group in the United States over the last decade and breast cancer incidence rates have increased in most Asian American groups in recent years [13]. How the requirement evolved: To identify distinct genomic alterations in Asian breast cancer patients and relate them to etiologic factors, we have collected fresh frozen and formalin-fixed paraffin-embedded (FFPE) breast tissue from breast cancer cases who were enrolled in a breast cancer case-control study led by Dr. Shelly Tse at Chinese University in Hong Kong (CUHK). Questionnaire data (including basic socio-demographic characteristics, lifetime habits of smoking and alcohol drinking, dietary habits and intake of supplements, anthropometric risk factors, reproductive factors, history of benign breast diseases, family cancer history of breast cancer, occupational and recreational physical activity, etc.) have been collected from more than 85% of cases and controls. Among breast cancer patients who consented to the tissue study, we have collected fresh frozen tissue from 400 breast cancer cases and FFPE tissue from ~300 patients. Using data and specimens collected from this study, we recently identified distinct subtypes among luminal tumors based on immune gene expression levels (manuscript under review), which may have important clinical implications in improving luminal breast cancer stratification for precision oncology treatment. Objective The overall goals of the Integrative Tumor Epidemiology Branch (ITEB) breast tissue study are to characterize the molecular/genomic profile of breast cancer in diverse populations and to associate the molecular changes with morphologic/radiologic changes, tumor subtypes, breast cancer risk factors (including genetic and environmental), and clinical characteristics. The specific aim for this procurement is to wrap up the collection of fresh frozen tissue and to support the collection of FFPE tissue, mammographic density data, and tissue storage and shipping in the two participating hospitals. Scope In support of the NCI Hong Kong breast cancer genomics study, the Chinese University of Hong Kong (CUHK) will recruit breast cancer patients and collect clinical and epidemiologic date and biospecimens. Contract Requirements The Contractor shall: 1. Transfer collected tissue from participating hospitals to the university, store fresh frozen tissue in liquid nitrogen, and ship them to NCI; 2. Purchase all supplies, and reagents required for the completion of the FFPE tissue collection; 3. Store collected sections in slide boxes at room temperature and ship to NCI twice a year; or upon request; 4. Obtain mammographic density (MD) data and assist the radiologists to collect and manage MD data. Clearances The NCI SSIRB approved the protocol of collecting tissue samples in HK in May 2013 (Project number: P131215). Chinese University of Hong Kong (CUHK) is uniquely qualified to perform this work because this will be a continuation of the previous work (HHSN261201400654P, HHSN261201700293P, HHSN2612018636P) of collecting breast tissue from breast cancer patients who participated in a breast cancer case-control study. In previous procurements, the NCI have successfully collected fresh frozen tissue from 400 breast cancer patients who had surgeries after the tissue study started in 2013. The goal of this procurement is to wrap up the collection of fresh frozen tissue and to support the collection of FFPE tissue, mammographic density data, and tissue storage and shipping in the two participating hospitals. Thus, the Chinese University of Hong Kong is the only known source that can meet NCI needs. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response 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 the requirement. Responses must be received in the contracting office by 11AM EST, on May 24, 2019. All responses and questions must be in writing and faxed to 240-276-5399 or emailed to Danielle Dade, Contracts Analyst via electronic mail at danielle.dade@nih.gov. 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 and have valid certification with the Online Representations and Certifications Applications (ORCA) managed through System for Award Management (SAM) at sam.gov. Reference: 75N91019Q00066 on all correspondence.