SOLICITATION NOTICE
B -- Evaluation of PAH Antibody Staining and TP53 Mutations
- Notice Date
- 8/17/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-90166-MM
- Archive Date
- 9/16/2009
- Point of Contact
- Melissa P Marino, Phone: 301-402-4509, Caren N Rasmussen, Phone: (301) 402-4509
- E-Mail Address
-
marinome@mail.nih.gov, cr214i@nih.gov
(marinome@mail.nih.gov, cr214i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Nutritional Epidemiology Branch (NEB), plans to procure on a sole source basis with International Agency for Research on Cancer (IARC), 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France an evaluation of PAH antibody staining and TP53 mutations on esophageal and gastric cancers. The North American Industry Classification System Code is 541712 and the business size standard in 500 employees. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The period of performance is twelve months from date of award. NEB conducts intramural research in areas related to nutrition and cancer aimed at lowering human cancer risk. One focus of NEB research is esophageal cancer, especially in high-risk populations. NEB scientists have performed studies of esophageal squamous cell carcinoma (ESCC) in high-risk areas of the world for over 20 years. An area of central Asia from the Caspian Sea in Iran to northwestern China has been identified as the Central Asian Esophageal Cancer Belt because the population throughout this region is at elevated risk of ESCC. The Western edge of this belt is Golestan Province, in northeastern Iran. One potential risk factor for ESCC in all countries is exposure to polycyclic aromatic hydrocarbons (PAHs). PAHs are carcinogens that can be found in food, tobacco smoke, and other natural and synthetic products, and have been linked to the etiology of skin and lung cancers in humans. The second most common cancer in Golestan is adenocarcinoma of the esophagogastric junctional and/or gastric cardia. The purpose of this study is to further explore the association of PAH exposure, ESCC and junctional adenocarcinomas by (a) creating an esophageal cell culture model to further evaluate PAH antibody staining patterns and PAH-adduct kinetics; (b) looking for TP53 gene mutations in the ESCC tumors of the Golestan Case-Control Study, to see if the mutation patterns suggest exposure to PAH or other carcinogens; and (c) looking for TP53 gene mutations in the esophagogastric junctional and gastric cardia adenocarcinomas from Golestan and Ardabil, to see if the mutation patterns are similar to those in the Golestan ESCC tumors and to see if they suggest exposure to PAH or other carcinogens. Specifically, the contractor shall: 1.Develop primary cell cultures of esophageal cells using a protocol for three-dimensional reconstitution over a matrix, treat them with PAH, stain them with anti-BPDE antibody 8E11, and assess the dose-response and the time course of adduct formation and clearance. Both data and pictures documenting the dose-response and time course findings will be provided. 2.Use these in vitro observations to perform further interpretation of the PAH staining patterns previously observed in tissue microarrays of non-tumor biopsies from cases and controls in the Golestan Case-Control Study. 3.Sequence the TP53 gene, exons 4-9, in tumor tissue from 167 ESCC cases from the Golestan Case-Control Study. 4. Sequence the TP53 gene, exons 4-9, in tumor tissue from esophagogastric junction and cardia adenocarcinoma cases from Golestan Province (n=100) and Ardabil Province (n=100) in northern Iran. Also stain these tumors with cytokeratins 7, 13, 19 and 20 to attempt stratification of the mutation results by the apparent site of tumor origin (esophagus vs. stomach). 5.Evaluate the TP53 sequence data from requirements 3 and 4, above, for mutation patterns associated with PAH or other carcinogen exposures, and compare this data with previous results from such tumors that are compiled in the IARC TP53 mutation database. An area of central Asia from the Caspian Sea in Iran to northwestern China has been identified as the Central Asian Esophageal Cancer Belt because the population throughout this region is at elevated risk of ESCC. The Western edge of this belt is Golestan Province, in northeastern Iran. This population was studied by the International Agency for Research on Cancer (IARC) in the 1970s, and IARC has recently begun studies in this region again, including a Case-Control study in Golestan Province which recruited 300 cases and 900 controls. IARC is the only major research institution conducting population-based studies of esophageal and gastric cancer in northern Iran, and it is the only source for biological samples from the Golestan Case-Control Study and from gastric cancer patients in Golestan and Ardabil Provinces, which are the biological samples required by this Statement of Work (SOW). IARC has a long history of quality research activities, including research in this area of Iran, so the data and samples that they have collected are of high quality. In addition, the IARC is the only lab in the world that has demonstrated the ability to develop primary cell cultures of esophageal cells for three-dimensional reconstruction over a matrix and is conducting high quality research on P53 (Requirements 3-5 of the SOW). This 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 the researcher to determine if the party can perform this requirement. An original and one copy of the capability statement must be received in the contracting office on or before 11:00 am ET on September 1, 2009 to Melissa Marino, Contract Specialist. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to marinome@mail.nih.gov. It is the vendor's responsibility to ensure questions have been received. 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 in and have valid certifications in the Central Contractor Registration (CCR), www.ccr.gov and the Online Representations and Certifications Application (ORCA) www.orca.bpn.gov. Please reference NCI-90166-MM on all correspondence.
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