SOURCES SOUGHT
B -- Trimethylamine N-oxide (TMAO) and Colorectal Cancer
- Notice Date
- 3/3/2014
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- HHSN-NIH-NCI-SBSS-TSB-44408-11
- Archive Date
- 3/25/2014
- Point of Contact
- Brenda Oberholzer, Phone: 301-624-8750
- E-Mail Address
-
oberholzerb@mail.nih.gov
(oberholzerb@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Trimethylamine N-oxide (TMAO) and Colorectal Cancer 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 sources 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) sources' 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 541990 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $14 Million. A. Background There is convincing evidence for a role of red and processed meat in colorectal cancer, but the mechanisms underlying the association between red/processed meat and colorectal cancer are not clear. Colorectal cancer is the third leading cause of cancer-related deaths in both men and women in the U.S. Elucidating the mechanism underlying the association between red/processed meat and colorectal cancer may help to identify intervention targets, which could reduce colorectal cancer morbidity and mortality. Recent studies demonstrated that trimethylamine N-oxide (TMAO) is produced from choline and carnitine, compounds found in large quantities in red/processed meat and produced by gut bacteria. Moreover, TMAO is associated with cardiovascular disease, atherosclerosis, and inflammation. NCI proposes that gut microbiota may be a major determinant in modifying colorectal cancer risk associated with red/processed meat intake via TMAO production. TMAO and the gut microbiota may account for inconsistent results from past studies, and may highlight the mechanism by which red/processed meat is associated with colorectal cancer. TMAO has been associated with increased inflammatory markers, which may impact cancer risk, and may also contribute to formation of the carcinogen N-nitrosodimethylamine. The Cleveland Clinic Lerner Research Institute will assess whether carnitine/choline and TMAO are associated with colorectal cancer in a case-cohort study nested in the ongoing Alpha-Tocopherol Beta-Carotene Trial (ATBC). Our primary aim is to determine the association between TMAO, as a potential integrative measure of red/processed meat intake and the gut microbiota, and colorectal cancer. The overarching goal is to provide insight into the mechanism underlying the association between red/processed meat intake and colorectal cancer. 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 Cleveland Clinic Lerner Research Institute in Cleveland, Ohio to provide assays of TMAO, carnitine, and Choline for 1500 samples obtained from the ongoing ATBC trials. Because this order is to continue on-going research already being performed by the Cleveland Clinic Lerner Research Institute, NCI believes that the Cleveland Clinic Lerner Research Institute is the only source capable of fulfilling this requirement. B. Purpose and Objectives of the Procurement This procurement will assess the role of carnitine/choline and TMAO in risk of colorectal cancer by assaying these compounds in sera in a case-cohort study nested within the ATBC Trial which is ongoing at the Cleveland Clinic Lerner Research Institute. This procurement will utilize serum samples from ~750 colorectal cancer cases and 750 controls in ATBC. Assays will be completed in Dr. Hazen's laboratory at the Cleveland Clinic, which has extensive expertise in TMAO plasma measurements. Cleveland Clinic Lerner Research Institute will measure serum carnitine, choline, and TMAO. TMAO will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS), the gold standard method for measuring TMAO. The Hazen laboratory already has panels set up to assay TMAO and many other analytes with this method. Choline and carnitine will be analyzed by stable isotope dilution LC/MS/MS analyses using established methods. For all assays, the laboratory will be blinded to case-cohort status. Each batch will include an equal distribution of colorectal cancer cases and disease-free individuals. 10% of the batch will include quality control samples used to calculate assay coefficients of variation. Our primary aim is to determine the main effects of TMAO on colorectal cancer. In order to fully explore this association, this procurement will also investigate the associations between serum precursors of TMAO (carnitine, choline) and the disease endpoint. Secondary aims are to: 1. Since TMAO is a biomarker only recently studied in relation to any disease, we will explore the associations that are related to the proposed role of TMAO in colorectal cancer, as shown in Figure 1. Specifically, this procurement will investigate the association between meat intake and serum metabolites (TMAO, carnitine, choline). This procurement will also explore the interrelationship between plasma TMAO, carnitine, and choline. Lastly, this procurement will determine whether there is an association between meat intake and colorectal cancer in the overall ATBC cohort (~29,000 men; ~ 825 cases) as well as the subset in which TMAO will be measured (~700 cases). 2. Investigate, in an exploratory analysis, whether TMAO is a mediator of the association between red/processed meat and colorectal cancer. C. Contractor Requirements The contractor shall perform the following tasks: 1. Receive and catalog approximately 1500 serum samples. The receipt of biologic samples should be logged in a MS Excel file including the information of ID, amount of serum received, and date of receipt. To facilitate this, an excel file will be provided by the Government and will include: sample ID and volume provided. The Contractor will add the date of receipt, an internal ID, test/assay date, and values for each serum measurement of interest. 2. Analyze carnitine, choline, and TMAO in 1500 serum samples using LC/MS/MS and record the results in the Excel file above. 3. Provide a plan for determining if the replicate values are in agreement and for repeat duplicates, as needed. Any insurmountable problems in the analysis of samples shall be reported to the Contracting Officer's Representative (COR) within three days of when they happen. 4. Send data to the NCI. 5. The dates of service will extend 5.5 months from the date of award (estimated period of performance is 05/01/2014-11/15/2014). To be deemed capable of providing the current need the organization 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 organizational and past experience in TMAO, carnitine, and choline plasma measurements through liquid chromatography-tandem mass spectrometry (LC/MS/MS). b. The offeror shall provide the name of the Principal Investigator, his/her professional qualifications and specific experience as a key investigator in measuring TMAO, carnitine, and choline plasma, as well as sufficient authority to assure access to facilities and records required for the project. c. The offeror shall demonstrate that the proposed team and staff have previous successful experience in carrying out the requirements of the services stated herein. 2. Facilities: Adequacy of facilities 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, at oberholzerb@mail.nih.gov by the 12 pm ET, March 10, 2014. 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. 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.
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