SOLICITATION NOTICE
B -- Expanded study of the “Molecular Epidemiology and Biology of Mammographic Density: The Breast Radiology, Evaluation and Study of Tissues (BREAST) Stamp project
- Notice Date
- 9/1/2009
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- 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-90232-AV
- Archive Date
- 9/26/2009
- Point of Contact
- Ashley L. Virts,
- E-Mail Address
-
virtsa@mail.nih.gov
(virtsa@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure on a sole source basis an expanded study of the "Molecular Epidemiology and Biology of Mammographic Density: The Breast Radiology, Evaluation and Study of Tissues (BREAST) Stamp project with the University of Vermont, Office of Health Promotion Research, 1 South Prospect Street, Burlington, VT 05401-3444. The services herein are being procured in accordance with the simplified acquisition procedures authorized by FAR Part 13. The North American Industry Classification System Code is 621511 and the business size standard is $13M The period of performance shall be four (4) months from date of award, with one seven (7) month option period. The NCI, DCEG has a longstanding interest in breast cancer research including methods for improved risk assessment, screening, early detection and prevention. Mammographic density is the strongest risk factor for sporadic breast cancer apart from age and gender. Improving measurement of breast density and delineating its molecular epidemiologic and biologic characteristics may be useful for developing improved risk assessment and prevention strategies. Researchers at NCI / DCEG / HREB, in collaboration with researchers at the University of Vermont have conducted a successful pilot study to develop methods to evaluate the molecular epidemiology and biology of mammographic density. Eligible subjects for this study were women between the ages of 40-65 years who were referred for radiologically-guided biopsy to evaluate an abnormality identified on a screening mammogram at the University of Vermont, Fletcher Allen Health Care. Obtaining state-of-the-art density measurements was a central component of the pilot and is integral to the study. To meet this requirement, the NCI has employed a novel technique for measuring breast density as a volume; this technique was developed by Dr. John Shepherd at the University of California at San Francisco (UCSF). For the pilot study, Dr. Shepherd and colleagues provided specifications for the construction of custom made density phantoms and insured proper installation of these phantoms on mammogram machines at the University of Vermont (UVM). These machines have been interfaced with computers to capture mammographic images including the breasts and phantoms in single views suitable for determination of density volumes using the UCSF software. Preliminary data generated with the method developed at UCSF and deployed at several sites have shown expected associations between risk factors and density, and between density and breast cancer risk. In addition to measuring density in the entire breast, the UCSF team has also developed methods for analysis of breast density in a specified volumetric region of interest (ROI) surrounding the biopsy site. Before the volumetric density in the ROI may be calculated by UCSF, the UVM team needs to review each subject's mammographic history and record the mammographic findings, biopsy coordinates, and rating for the level of confidence in the biopsy location identified on the mammogram of interest. The purpose of this requirement is to continue enrollment through December 31, 2009 (Phase I) and provide for an optional extension of the study through July 31, 2010 (Phase II) if quality of biological specimens and collected data are confirmed. The University of Vermont is uniquely qualified to conduct this study because of its position as a Breast Cancer Surveillance Consortium (BCSC) site with availability of radiology and pathology collaborators, a tissue collection team, and a General Clinical Research Center enabling rapid processing of blood and mouthwash specimens. As part of the BCSC, the University of Vermont can provide questionnaire data and medical records for two years prior to enrollment, and because of a stable patient base, follow-up data for up to 10 years. Maintaining a consistent study protocol is necessary for extending the NCI pilot and providing data to other sites within the Breast Cancer Surveillance Consortium. A critical component of this study is measuring mammographic density using software and hardware installed at the University of Vermont that were developed by Dr. Shepherd and colleagues at the University of California at San Francisco (UCSF), the inventors and only source with this technology. UCSF developed the volumetric density methods, which included designing and validating breast density phantoms, and supporting installation of hardware and software and related quality assurance programs at the University of Vermont. These novel approaches will enable the NCI to address important questions that remain unanswered in the literature related to the relationship of density surrounding a biopsy and lesion severity and variation of density within the breast. The procedures for pursuing these aims have been developed with the University of Vermont radiology team, the only group which has experience with these analyses, in conjunction with UCSF and NCI. Many of these methods are dependent on mammography machines and practices, and continuity is essential for developing data comparable to those generated in the pilot. The status of the University of Vermont as a BCSC site will permit novel analyses comparing density measurements in the study to data collected prior to enrollment, as well as future mammographic and clinical results accumulated following enrollment. Ongoing projects within the Breast Cancer Surveillance Consortium have already begun instituting the Shepherd method. Therefore, maintaining consistency within the Consortium will provide opportunities to pool data across sites. 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 11, 2009. All questions must be in writing and can be faxed to 301-402-4513 or sent via email to Ashley Virts at virtsa@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-90232-AV on all correspondence.
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