SOLICITATION NOTICE
B -- Study to Examine Melanocytic Nevi to Dysplastic Nevi to Melanoma in Patients Recruited at the University of L’Aquila.
- Notice Date
- 9/4/2009
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-90244-MM
- Archive Date
- 10/6/2009
- 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), Genetic Epidemiology Branch, plans to procure on a sole source basis with Maria Concetta Fargnoli, University of L'Aquila, Department of Dermatology, Via Vetoio Coppito 2, 67100 L'Aquila, Italy, for a study to examine factors involved in transition from common melanocytic nevi to dysplastic nevi to melanoma in patients recruited at the University of L'Aquila. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13.106-1 (b) (1). The North American Industry Classification System Code is 541690 and the business size standard is $7.0M. The period of Performance shall be twelve (12) months from date of award. Individuals with fair pigmentation, low tanning ability, germline mutations in susceptibility genes, and many melanocytic nevi or dysplastic nevi, are at increased risk of developing melanoma. However, these risk factors may lead to melanoma formation through multiple pathways. For example, among subjects at high risk, fair-skinned red heads are often prone to freckling but have few melanocytic nevi, and others who may have darker skin complexion but many nevi. In addition, only 20-30% of melanoma lesions are histologically associated with a pre-existent nevus, and melanomas in chronically sun exposed areas of the body tend to arise in subjects with few melanocytic nevi, even though sun exposure is associated with nevi formation. The investigation into molecular distinctions between individuals who develop melanomas through different avenues may allow the tailoring of public-health messages to the specific population at risk. The NCI has designed a study to investigate whether there are signs of a direct transition from common melanocytic nevi to dysplastic nevi to melanoma. The study will focus on the comparison of gene expression from different tissue types (normal skin, nevi, and melanoma) from the same individuals. In addition, the study will compare gene expression with protein profile and genotype of the same subjects. Epidemiological and clinical data will be collected as well as photographs of the skin lesions of interest. The purpose of this contract is to support subject enrollment for the study, skin examination of the participants, identification of dysplastic nevi to be photographed, recruitment of families if the participants have at least two relatives with melanoma, and collection of fresh frozen and fixed tissue samples and blood samples. The NCI has successfully conducted a case-control study of melanoma at the University of L'Aquila, Italy in collaboration with Professor Maria Concetta Fargnoli, and have piloted the use of the same tools and screening criteria for nevi and pigmentation characteristics and epidemiological data collection. The NCI needs to recruit participants for this current study from the same area as the previous studies, in order to compare the results with those obtained in subjects with similar background, history of sun exposure, and genetic make-up. The study at the University of L'Aquila will be conducted by Professor Maria Concetta Fargnoli, a trained dermatologist in the recognition of dysplastic nevi and melanoma; she will be able to select the fragment of tissue lesion that is needed for the research in collaboration with pathologists of the university and ensure continuity in the research. In addition, Professor Fargnoli has acquired expertise in the practical aspects involved in the management of data, photographs, clinical forms, informed consents, and biospecimens, in accordance with NCI standards and needs, and has access to medical records from the University dermatology department, which are crucial for study comparisons. Because of the necessity to recruit subjects similar to those recruited in the past, the work at the University of L'Aquila, under the direction of Professor Fargnoli is irreplaceable. 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 NCI to determine if the party can meet this requirement. One (1) original and one (1) copy of the capability statement must be received in the contracting office by 11:00 a.m. ET on September 21, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Melissa Marino at 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, contractor must have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Application (ORCA). Please reference NCI-90244-MM on all correspondence.
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- SN01942792-W 20090906/090905002748-9bf04bc91b757f4f5f50238c91f77783 (fbodaily.com)
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