SOURCES SOUGHT
B -- Prevalence and Molecular Characteristics of Monoclonal B-cell Lymphocytosis among Blood Donors Aged 45 Years and Older
- Notice Date
- 6/28/2010
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2010-82860
- Archive Date
- 7/28/2010
- Point of Contact
- Tayaria L Smith, Phone: 7704882797
- E-Mail Address
-
gqq4@cdc.gov
(gqq4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers of Disease Control and Prevention intends to award a sole source, firm fixed price contract, in accordance with FAR Part 13, using simplified aquistion procedures, to the Universita Vita-Salute San Raffaele, Via Olgettina, 58 20132 Milano, Italia. The Universita Vita- Salute San Raffaele will deleiver the following peformance work statement. Perfomance Work Statment Title of Project: Prevalence and Molecular Characteristics of Monoclonal B-cell Lymphocytosis among Blood Donors Aged 45 Years and Older C.1 Background and Need - Chronic lymphocytic leukemia (CLL) is the most common form of leukemia found in adults in the United States. As the proportion of older people has increased with improved life expectancy in the Western world, the burden from CLL has also increased. The American Cancer Society projected 15,490 new cases for 2009, a substantial increase from the 11,168 new cases reported in 2005. The disease burden is also significant in the European Union, with an estimated 46,000 individuals in 2006 living with CLL, 5 years post-diagnosis. The clinical picture of CLL is quite variable; some patients live a normal life span and die of apparently unrelated causes, while others progress rapidly and succumb to clinical disease. The necessary step toward CLL is uncontrolled proliferation of a single B-cell clone. When the presence of a monoclonal B-cell expansion is detected in the peripheral blood of a person who does not have CLL or other B-lymphoproliferative disorders, the condition is described as monoclonal B-cell lymphocytosis (MBL). While some individuals with MBL have an elevated risk for developing CLL, MBL may also persist silently for years without clinical progression or even show apparent regression. For CLL, the mutation status of the IGVH gene (i.e., germline or somatic) has been identified as a strong prognostic factor, independent of other factors. In MBL, however, the IGVH mutation status has not been well characterized. The first studies of MBL in the general population were conducted during a series of environmental health investigations in the United States. From 1991 to 1994, ATSDR conducted a number of cross-sectional studies, comparing individuals living near hazardous waste sites to persons living in the comparison communities. Using a standardized panel of immune biomarkers, approximately 6,000 individuals were tested in collaboration with NCEH and CDC. MBL was observed as an unexpected finding in 11 individuals, the youngest of whom was age 47. Medical follow-ups were conducted in 1997 and 2003, and results confirmed that MBL can progress to chronic lymphocytic leukemia and other B cell lymphoid malignancies. Blood donor populations can provide an efficient means of obtaining prevalence estimates of MBL in healthy populations. Rachel et al (2007) reported an MBL prevalence of 0.14% (7 out of 5,138) among blood donors of all age groups in a community blood centers in the Midwest region of the United States. This prevalence rate (0.14%) is considered a low estimate, because of the low sensitivity of the laboratory techniques utilized. Additional studies are needed to understand the prevalence of MBL in healthy individuals and the associated molecular characteristics, in particular the IGVH mutation status. C.2 Project Objective - The objective of this project is to characterize the IGVH mutation status of the B-cell clones detected in blood donors. The mutation status of the IGVH genes (i.e., mutated vs. unmutated) has been identified as a strong prognostic factor for CLL, independent of other factors. C.3 Scope of Work - This project will perform the IGVH gene mutation analysis of the B-cell clones detected in blood donors. Polymerase chain reaction (PCR) will be carried out for amplification and sequence analysis of IGVH genes. The proportion of unmutated IGVH genes as well as the usage of IGVH genes will be determined. C.4 Technical Requirements - • Obtain a local institutional review board (IRB) approval or exemption of the study protocol, as appropriate. • Retrieve the specimens after completing customs clearance. • Adhere to the specimen handling procedures described in the study protocol. • Complete IGVH gene rearrangements and sequence analyses. • Generate reports describing the laboratory methods, test results, and interpretations of the results. • Participate in conference calls as needed. • Collaborate with co-investigators in analyzing study results and preparing manuscripts for journal submissions. C.5 Reporting Schedule - • Submit an electronic progress report every 90 days from the date of this contract award. The report should include the laboratory methods, test results, and interpretations of the results. The test results should be provided in an Excel file and include explanations for results that did not meet the requirements. • Submit an electronic final report at the end of the project. The final report should summarize all results with interpretations. • Report any needs to amend the study protocol, as they are identified. • Report any unexpected issues involving handling of specimens, as they arise. C.6 Special Considerations - The generated data should not be used without CDC approval. C.7 Government Furnished Property -None C.8 References - • Landgren et al confirmed the presence of a prediagnostic B-cell clone (MBL) in 35 of the 45 CLL patients and characterized the immunoglobulin gene repertoire. (Landgren O, Albitar M, Wanlong MA, Abbasi F, Hayes RB, Ghia P, Marti GE, Caporaso NE. B-Cell clones as early markers for chronic lymphocytic leukemia. N Engl J Med 2009;360:659-667) • Dagklis et al analyzed IGVH-D-J rearrangements in 51 CLL-like MBL cases from healthy individuals, characterized by few clonal B cells. Seventy percent of the IGVH genes were mutated. (Dagklis A, Fazi C, Sala C, Cantarelli V, Scielzo C, Massacane R, Toniolo D, Caligaris-Cappio F, Stamatopoulos K and Ghia P. The immunoglobulin gene repertoire of low-count CLL-like MBL is different from CLL: diagnostic implications for clinical monitoring. Blood 2009;114:26-32) C.9 Deliverables - • Submit the Laboratory Standard Operating Protocol to project officer before study samples are analyzed. • Submit an e-mail documenting local IRB approval (or exemption). • Submit the identification numbers of the specimens, as they are retrieved. • An electronic progress report every 90 days, including dataset. • A final report. • A final dataset, including all samples analyzed, as an Excel file. Delivery Schedule Item Description Quantity Delivery Date Deliver To Laboratory Standard Operating Protocol (electronic file) 1 2 weeks after date of award PO Documentation of local IRB approval or exemption (e-mail or Fax) 1 1 month after date of award PO Specimen identification numbers (electronic file) 1 As the specimens are received PO Progress report, including dataset (electronic file) 1 Every 90 days from the date of this contract award. PO Final dataset (Excel file) 1 Due within 30 days prior to award expiration PO Final report (electronic file) 1 Due within 30 days prior to award expiration PO C.10 Period of Performance - The period of performance under this contract shall not exceed 24 months from the date of award. The Universita Vita-Salute San Raffaele appears to be the only organization that can provide the services to meet all the program requirements including cost and time constraints, and has expertise in characterizing IGVH mutation in low count MBL that are mainly identified in healthy individuals, in addition to working in clinical settings.. No Request for Propasal (RFP) will be issued based upon this Notice of Intent. Any interested compaines are welcome to submit there credentials and ability to provide the services, via e-mail, gqq4@cdc.gov. Include reference number ( 2010-82860). Send responses by 7/13/2009.
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