MODIFICATION
B -- Trimethylamine N-oxide (TMAO) and Colorectal Cancer
- Notice Date
- 4/4/2014
- Notice Type
- Modification/Amendment
- 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
- N02CP44408-11
- Archive Date
- 5/6/2014
- 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
- General Information Title: Trimethylamine N-oxide (TMAO) and Colorectal Cancer Document Type: Presolicitation Notice Solicitation Number: N02CP44408-11 This amendedment is reposting this Presolicitation Notice Posted Date: 04/04/2014 Response Date: 04/21/2014 Classification Code: Q301 Laboratory Testing Services NAICS Code: 541990 Professional, Scientific, and Technical Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, Riverside Five, Suite 400, Room 4032, 8490 Progress Drive, Frederick, MD 21701, UNITED STATES. Description 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, the Cleveland Clinic Lerner Research Institute is the only source capable of fulfilling this requirement. The services herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14 million. 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 shall be 5.5 months from date of award (est. 5/1/2014-10/15/2014). 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. 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. 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. 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 05/01/2014-10/15/2014). This notice is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities 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. Capability statements must be received in the contracting office by 12:00 PM ET, on April 21, 2014. For further information, please contact Brenda Oberholzer, Contracting Officer via electronic mail at oberholzerb@mail.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. No faxed or emailed capability statements will be accepted. In order to receive an award, contractors must be registered and have valid certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) thru sam.gov. Reference: N02CP44408-11on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02CP44408-11/listing.html)
- Place of Performance
- Address: contractor location, United States
- Record
- SN03330795-W 20140406/140404235028-50bd930b129a54291b06210b7407efb2 (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 |