SOURCES SOUGHT
A -- Recruit Breast Cancer Patients and Collect Clinical and Epidemiological Data and Biospecimens - Statement of Work
- Notice Date
- 8/5/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- HHS-NIH-NCI-SBSS-TSB-34405-11
- Archive Date
- 8/28/2013
- Point of Contact
- Brenda Oberholzer, Phone: 301-228-4216, Brian Madgey, Phone: 301 624-8760
- E-Mail Address
-
oberholzerb@mail.nih.gov, brian.madgey@nih.gov
(oberholzerb@mail.nih.gov, brian.madgey@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Work Recruit Breast Cancer Patients and Collect Clinical and Epidemiological Data and Biospecimens This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541711 in the North American Industry Classification System (NAICS), and the size standard for such requirements is 500 employees. Previous molecular classification studies in Asian breast cancer are limited and have generated inconsistent data. Results from some studies suggest that Asian women were more likely to develop TN tumors compared with white women (32). In contrast, data based on the California Cancer Registry suggested that Asian women had lower risk of developing TN tumors but higher risk of HER2-overexpressing tumors (33-35). In addition to the inconsistency, it is unclear or is simply due to lower incidence of ER+ tumors. Tumor stratification in previously conducted studies was mostly based on clinical markers only (eg. ER, PR, and HER2), and used varying criteria to define positivity and little or no quantitation. A more refined molecular classification approach is needed to achieve more accurate tumor stratification and to identify etiologic factors underlying specific tumor subtypes, which will help distinguish the interrelated effects of age and race in breast cancer. In addition, Asian breast cancer shows great heterogeneity by population/ethnicity, geographic region, and level of economic development. Incidence rates and tumor characteristics vary even within the same geographic areas. Differences in both genetic and environmental risk factors may contribute to the variations, and studying a variety of Asian populations will improve our understanding of the etiologic heterogeneity of breast cancer. Therefore we propose to conduct a molecular epidemiology study by collecting normal and breast tumor tissues from breast cancer cases who are enrolled in an ongoing breast cancer case-control study (Night shift and breast cancer: a case-control study among Hong Kong women) led by Dr. Shelly Tse at Chinese University in Hong Kong (CUHK). Eligible cases in the nightshift and breast cancer case-control study are identified from the Surgery or Oncology Departments of hospitals in three clusters in Hong Kong. Each case is frequency-matched in five-year age groups to a hospital control who is randomly selected from the same hospital where the case comes from. All cases and controls are Chinese females, and all controls have no history of a physician-diagnosed cancer at any site. Approximately 1,000 incident female breast cancer cases and 1,000 age-matched controls are expected to be recruited into the case-control study by the end of year 2013. 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) and blood are being collected from each participating subject. Dr. Tse has submitted a grant to the Research Grants Council in Hong Kong to expand the current case-control study. If funded, an additional 2,000 cases and 2,000 controls will be recruited from the same catchment areas between Jan. 2014 and December 2016. The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), is anticipating to award a Firm-Fixed Price non-competitive purchase order to The Chinese University of Hong Kong, in Hong Kong SAR, China to provide recruitment of patients, collection of samples, and the related epidemiologic data from Asian populations. Contractor Requirements: The contractor shall: 1. Recruit ~2000 breast cancer cases and appropriate controls from a major city in China or Hong Kong where a population-based cancer registry is available and accessible; 2. Collect blood DNA and 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.) from all study participants; 3. Collect medical records and pathology reports from all participating breast cancer cases; 4. Obtain written inform consent from study participants for tissue collection; 5. Collect fresh frozen breast tissues (two non-malignant and one tumor, frozen within 30 minutes after surgical excision) and five 10 um sections from FFPE blocks (two non-malignant and one tumor); 6. Store collected tissues properly (fresh frozen tissues in liquid nitrogen and FFPE tissue slides in tubes at room temperature) until the shipment to NCI; 7. Ship the tissue samples to NCI every 4-6 months; 8. Share clinical and epidemiologic data with NCI COR. To be deemed capable of providing the current need the offeror must submit a written capability statement. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: 1. Personnel/Experience: a. Proven experiences in designing and conducing epidemiologic studies. b. Proven organizational and past experience in recruiting patients and healthy controls, tissue and data collection, tissue storage and shipment. c. The offeror shall provide the name of the Principal Investigator, his/her professional qualifications and specific experience as a key investigator in recruiting patients and tissue collection and possessing sufficient authority to assure access to facilities and records required for the project. d. The offeror shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein and collect all data and biospecimens within two years. 2. Facilities: Adequacy of facilities for patient recruitment, tissue collections, research for performing the Statement of Work. If any responsible source believes it can perform the requirements they may submit their capability statements via email (PDF format; 15 Page Limit, these pages exclude resumes) for consideration by NCI to Brenda Oberholzer, Contracting Officer, and Brian Madgey, Contract Specialist at the e-mail addresses provided by the response date. No collect calls or facsimile transmissions will be accepted. Respondents must include DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE, etc) pursuant to the applicable NAICS code. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation(s). Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/HHS-NIH-NCI-SBSS-TSB-34405-11/listing.html)
- Record
- SN03137437-W 20130807/130805234654-eb2c35b63800171fc33c4ba057925ed5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |