MODIFICATION
A -- The National Myelodysplastic Syndromes (MDS) Natural History Study- Central Laboratory and Biorepository - Solicitation 1
- Notice Date
- 3/20/2013
- Notice Type
- Modification/Amendment
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-ECB-HB-2014-06-AC
- Response Due
- 6/5/2013 3:00:00 PM
- Point of Contact
- Allison M Cristman, Phone: 301-435-0359, Sarah Bank, Phone: (301)435-2158
- E-Mail Address
-
allison.cristman@nih.gov, Sarah.bank@nih.gov
(allison.cristman@nih.gov, Sarah.bank@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation document including attachments. The NHLBI is seeking a Central Laboratory and Biorepository (CL/B) for a new program, The National Myelodysplastic Syndromes (MDS) Natural History Study (The National MDS Study). THIS IS A REQUEST FOR PROPOSALS (RFP). Background and Program Objectives The National Heart, Lung, and Blood Institute (NHLBI) is seeking to better understand the progression of myelodysplastic syndromes (MDS) through the initiation of an observational study of adults newly diagnosed with MDS, titled The National Myelodysplastic Syndromes Natural History Study (The National MDS Study). An estimated 20,000 or more new cases of MDS are diagnosed in the United States each year. The incidence of MDS dramatically increases with age. MDS is a heterogeneous collection of clonal blood disorders characterized by ineffective hematopoiesis leading to anemia, neutropenia, and thrombocytopenia. While most cases occur in older adults, chemotherapy and other toxin-induced MDS and MDS due to inherited disorders occur in younger persons as well. Those suffering with this syndrome are predisposed to lethal infections, iron overload from repeated transfusions, and life-threatening bleeding. Some patients with MDS can develop chemotherapy-resistant acute myeloid leukemia. Most therapies for MDS are suboptimal and not curative. MDS is frequently asymptomatic, but clinically suspected in older patients with abnormal routine blood tests, recurrent infections, or excessive bleeding. Diagnosis requires evaluation of bone marrow for evidence of cells that are maturing abnormally and malignant cells. These findings, combined with peripheral cytopenia(s), abnormal bone marrow cytogenetics, and the degree of transfusion dependence, have been used to classify patients with MDS into risk groups and provide a general assessment of disease severity and possible prognosis. However, biomarkers that are clinically useful for accurate diagnosis, prognosis, and prediction of a patient's response to therapy are not available. The etiologies of MDS are not well defined. Distinct mutations and genetic modifications are thought to underlie the molecular basis of MDS, some of which may be independent predictors of poor survival. A comprehensive standardized longitudinal clinical dataset and a consistently-processed, well-annotated biospecimen collection will provide national resources that potentially can be used to: (1) identify genetic, epigenetic and biological factors associated with initiation and progression of MDS; (2) uncover fundamental information on the changes that occur in hematopoietic stem cells and bone marrow stroma during normal aging; (3) reveal clinically useful biomarkers; (4) identify potential targets for new interventions; and (5) facilitate understanding of how patients with MDS are managed in practice. These resources will facilitate the conduct of basic and translational research on the evolution of MDS over time, and improve the diagnosis and clinical management of affected individuals. Project Requirements This requirement is for a Central Laboratory and Biorepository (CL/B). During the contract period, this new program will establish a cohort of up to 2,000 adults recently diagnosed with MDS, and up to 500 age-matched participants who are not diagnosed with MDS, but who are clinically suspected of having this syndrome. The National MDS will create a comprehensive standardized longitudinal clinical dataset linked to a prospective collection of high-quality, well-characterized biospecimens to advance the understanding of disease progression. The National MDS Study protocol will define the clinical data and biospecimens to be collected, and research studies that will be performed on biospecimens to provide additional data (genetic, molecular, and biological) to enrich the value of the clinical data set and the biospecimen collection. The biospecimen collection, clinical data set, and datasets generated by the protocol-defined research studies will support current and future research in MDS, and be made available to the scientific community as national resources to encourage research to advance the understanding of the biology and genetics of these syndromes. Overall coordination of The National MDS Study will be performed by a Data Coordinating Center (DCC; Solicitation No. NHLBI-ECB-HB-2014-05-AC). The CL/B will collaborate with the DCC and experts appointed by NHLBI to develop a protocol for The National MDS Study, conduct the study, and build a resource that will be comprised of well-annotated, quality biospecimens linked to comprehensive clinical, genetic, and molecular datasets. The CL/B will provide the scientific and technical expertise and the facilities to design, build, and store a quality biospecimen collection that will be linked to phenotypic, molecular and genotypic data. The biospecimens will be collected from participants enrolled at multiple clinical sites. The CL/B will also perform research assays defined in the study protocol and transfer the biospecimen collection to a new facility at the end of the contract. During the contract period, biospecimens will be made available to the wider scientific community for approved scientific research protocols following procedures established by the NHLBI and The National MDS Study. At the end of the contract, the resource will be made available through the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) program (www.biolincc.nhlbi.nih.gov). The CL/B is expected to provide the necessary technical expertise and facilities to effectively perform the tasks and meet the requirements identified below: 1. Experienced and highly competent in managing a central laboratory, performing and interpreting research assays, and designing and building hematological biospecimen collections for multi-center clinical studies. 2. Key personnel with demonstrated knowledge and leadership, as attested by his/her publication record, in: designing hematological biospecimen collections for multi-center clinical studies; serving as a central laboratory for multi-center clinical studies storing hematological biospecimens (e.g., bone marrow, plasma, serum, whole blood); and performing research using fresh and frozen samples. 3. Key personnel with demonstrated knowledge in developing and implementing procedures to establish a central laboratory and build a biospecimen collection for multi-center clinical studies, and managing multi-center clinical study central laboratories and biospecimen collections. 4. Receive, process, inventory, aliquot, store, retrieve, distribute, and track hematological biospecimens, including histopathology slides, collected on multi-center clinical studies using validated procedures. 5. Perform research in MDS using fresh and frozen samples and interpret and apply the results, including performing and interpreting immunophenotyping assays, and isolating cell populations. 6. Provide a validated electronic biospecimen and laboratory management system and customize the system to enable study-specific functions to be performed. 7. Develop and distribute study-specific barcode label sets, collection kits, forms, and shipping materials to collection sites. 8. Develop, implement, and manage a program to train site personnel to perform study specific procedures and monitor collection site performance. 9. Transfer a biospecimen collection and all associated electronic documents and data files in a secure and safe manner to a new facility. Other Important Considerations Under this solicitation, the Government anticipates award of one (1) Indefinite Delivery, Indefinite Quantity (IDIQ) contract with cost-reimbursement task orders for a period of approximately seven to eight years with an estimated award date of July 1, 2014. The Government is not committed to award a contract pursuant to this announcement. The offeror is responsible for monitoring the FedBizOpps Web page for the release of any amendments.
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- Record
- SN03016484-W 20130322/130320234525-df0c32d1635390d64ec807a20d3ca6f7 (fbodaily.com)
- Source
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