National Cancer Institute, Research Contracts Branch, CECS, 6120 Executive Blvd, EPS/Room 620, MSC 7224, Bethesda MD 20892-7224

A -- PROSPECTIVE IMMUNOEPIDEMIOLOGIC STUDY OF LOW-GRADE SQUAMOUS INTRAEPITHELIAL LESIONS OF THE CERVIX (LOW-GRADE SIL) SOL RFP-N01-CP-61019-21 DUE 041896 POC Barbara A. Shadrick, Contracting Officer, 301/496-8611. The Environmental Epidemiology Branch (EEB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), is seeking offerors for a new contract to process, store, test, and ship blood samples collected as part of a large prospective study of immunological markers involved in the pathogenesis of cervical neoplasia. As a Mandatory Requirement, offerors are required to be located within one hour driving distance of the main campus of the National Institutes of Health (NIH). The study, in which 7,200 women with low-grade cervical lesions will be enrolled over an 18-month period and followed at six-month intervals for an average of four years, is designed to assess cell-mediated immune parameters among study participants and to determine whether these immune markers are predictive or correlate with disease progression and regression. The offeror must have demonstrable experience in conducting immunological assays on a large number of specimens. Experience in data management and sample tracking of large number of specimens and assay results is also essential. The assays to be performed under this contract are highly technical, research-based assays which require well-trained, experienced, and dedicated personnel. Services to be provided by the contractor shall include: 1) Receipt and logging of fresh peripheral blood samples, 2) timely separation and cryopreservation of PBMCs from fresh whole blood, 3) separation and storage of plasma and red blood cells from fresh whole blood, 4) establishment of EBV-transformed PBMC lines, 5) performance of immunologic assays using PBMCs isolated from whole blood, including lymphocyte proliferation in response to virus-specific antigens, measurement of cytokine levels produced by PBMCs in culture in response to stimulation with virus-specific antigens, and measurement of cytotoxic response of PBMCs stimulated by virus-specific antigens against virus antigen expressing target cells in vitro, 6) computerization of individual assay results, 7) storage of cryopreserved materials in small aliquots in mechanical and liquid nitrogen freezers, 8) preparation of frozen samples for shipment to the NCI repository, and 9) maintenance of strict and well documented quality control procedures. At initiation of the contract, the offeror shall work closely with the NCI Project Officers to standardize and finalize the protocols to be used at the offeror's laboratory during the period of the contract. The offeror shall receive fresh whole blood samples from four clinical centers on a daily basis. The offeror shall be capable of developing mechanisms to communicate with the four clinical centers and the coordinating unit regarding the type, volume and timing of specimen shipments. All biospecimens stored in the repository must be entered into the Biospecimen Inventory System (BSI). The BSI is an information system designed to track and control the acquisition, storage, requisition and distribution of biological specimens. Training and documentation on the use of the BSI will be provided by the NCI at no cost to the contractor. It is anticipated that the proposed contract will be a cost-reimbursement, completion type contract for a four-year period of performance. All responsible sources capable of providing this support and meeting these criterion are encouraged to submit an offer and will be considered by the NCI. The RFP will be available on/about March 19, 1996. Proposals will be due approximately 30 calendar days after the actual issuance date of the RFP package. Award is anticipated by September 1, 1996. NO collect calls will be accepted (0053)

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