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Support Services for the uropathological data of inflammatory microenvironment in kidney cancers being molecularly profiled at NCI.


Maryland, United States
Government : Federal
RFP
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Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E224, Rockville, MD 20850, UNITED STATES


Description


The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) plans to procure on a sole source basis services to Retrieve tumor blocks, review diagnoses, stain slides and record in corresponding database the percentage of granulocytes (PMNs, eosinophils) and stroma and conduct immunohistochemistry analyses, record percentage of lymphocytes. from Dr. Steno Sentinelli, Via di Villa Betania 4, 00165, Rome, Italy.


The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(2), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $15.0M.


Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.


The period of performance is shall be as follows:


Base Period - Twelve (12) months from its execution date.
Option Period 1 - Twelve (12) months from its execution date.


It has been determined there are no opportunities to acquire green products or services for this procurement.


The Division of Cancer Epidemiology and Genetics (DCEG) is an intramural research program of the National Institutes of Health (NIH), National Cancer Institute (NCI), that conducts population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention.


The purpose of this procurement is to fund uropathological data of inflammatory microenvironment in kidney cancers being molecularly profiled at NCI. This work will include 240 cancers within a two-year period.


The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to discover the genetic and environmental determinants of cancer etiology and progression. The tumor microenvironment plays a crucial role in cancer development and thus it is a very important DCEG research objective, particularly within epidemiological investigations. DCEG has invested large resources to characterize the genomic landscape of kidney tumors and needs to examine the relationship between tumor mutation profile and immune infiltrate in the tumor microenvironment. for lung cancer and to provide additional evidence that diesel exhaust causes bladder cancer.


The tumor microenvironment encompasses a wide variety of cells including malignant and non-malignant populations. Non-malignant populations include stromal cells, an expanding vasculature, and a leukocyte infiltrate. Macrophages comprise the dominant portion of the leukocyte population. These "tumor associated macrophages (TAMs)" have served as an example of the "smoldering" cancer related inflammation, suggested recently to represent the 7th hallmark of cancer. Not only is this inflammation present in the microenvironment of most neoplastic tissues, but there is accumulating evidence suggesting that this inflammation, with myeloid cells as key mediators, actively promotes all aspects of tumor growth and development. In contrast, studies examining immune cell tumor infiltrates have shown that presence of cytotoxic T lymphocytes in the tumor microenvironment is associated with improved survival among patients with several cancers. Yet, these studies have either focused on only a small sample or have not differentiated by histological subtypes. It is unknown how these associations vary by histology and treatment and how the tumor molecular profile impacts the tumor inflammatory microenvironment. To date, no comprehensive, population-level study has intensively examined these relationships.

Novel immunotherapies, including monoclonal antibodies directed against inhibitory immune checkpoint proteins such as CTLA-4, PD-1, and PD-L1, have recently shown clinical efficacy for patients with unresectable disease and/or distant metastases. Despite such exciting developments, however, biomarkers for prediction of response to immunotherapy remain elusive. Understanding the relationship between tumor evolution and tumor microenvironment can help clarify these issues and possibly identify molecular signatures predictive of the response to immunotherapy.


The Contractor shall perform the following tasks:


1. Retrieve tumor blocks from the Regina Elena Cancer Institute pathology archive correspondent to the tumors being profiled at the NCI.
2. Review correspondent diagnoses. The tumors are archived with a diagnosis. The pathologist has to review the diagnosis to confirm it is correct. It is done under the microscope. If the diagnosis is not correct, the pathologist needs to exclude that tumor from the analysis. There is no travel involved to perform the diagnoses.
3. Stain slides and record in corresponding database provided by the NCI the percentage of granulocytes (PMNs, eosinophils), and stroma.
4. Conduct immunohistochemistry analyses and record percentage of Cytotoxic T lymphocytes (CD8+), T helper lymphocytes (CD4+, CD8-, FOXP3-), Regulatory/Suppressor T lymphocytes (CD4+, FOXP3+), macrophages (CD68+) M1 macrophages (CD68+, HLA-DR+), M2 macrophages (CD163+) and endothelial cells (CD31+).
5. Send correspondent filled-in database provided by the NCI to the NCI Technical point of contact.


It is expected that the laboratory will exercise the above listed requirements for 30 tumors every three months, for a total of 120 tumors the first year and an additional 120 tumors the following year.


Government Responsibilities: At the time of the award, the NCI will coordinate data of the material to be evaluated. The NCI will outline the data to be reported for each tumor.


Reporting Requirements and Deliverables:
1. Every three months the contractor shall provide data via email corresponding to 30 tumors to the NCI Technical Point of Contact as follows during both the Base Year and Option Year 1:
a. An electronic manifest indicating the identified 30 kidney tumors
b. Pathology database for the 30 kidney tumors including details on inflammatory cells, stroma and endothelial cells as defined in Section C.


2. The contractor shall communicate the study progress in a monthly written report via email to the NCI Technical Point of Contact.


Inspection and Acceptance Requirements: The reports, containing relevant data items, mentioned above will be scrutinized and subsequently accepted within fifteen (15) business days of receipt. If no comments or request for revisions are provided within fifteen (15) business days, the deliverables shall be considered acceptable.
Clearances: The study has received OHSR exemption (#12196).
Options are included in the SOW:
FAR Clause 52.217-9, Option to Extend the Term of the Contract (March 2000).
"(a) The Government may extend the term of this contract by written notice to the
Contractor within 45 days; provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least 45 days before the contract expires. The preliminary notice does not commit the Government to an extension."


Payment shall be made in arrears after receipt and acceptance of each deliverable. Payment authorization requires submission of an invoice per the Invoice & Payment Provision included in the order.


These support services are provided by Dr. Steno Sentinelli. The NCI is conducting in depth molecular profiling of 120 tumors from the Regina Elena Cancer Institute in Rome, Italy. The tumors are archived at the Institute and have been examined in the past by Dr. Steno Sentinelli, a dedicated Uropathologist. Since the tumor blocks are archived in this Institute, and the NCI needs detailed data on the inflammatory microenvironment of the tumors being molecularly profiled, the NCI needs the same pathologist who reviewed the cases and has access to the archive to provide this service.


Dr. Steno Sentinelli has worked at the Regina Elena Institute for 15 years and has permission from the institute to continue to work on the archived tissue under this collaboration with the NCI. Dr. Sentinelli is well known for his expertise in urological pathology, and in particular in kidney cancer evaluation. He examines an average of 150 tumors cases/month and has contributed to many scientific studies, which led to important publications (a few examples listed below). The pathology department at the Regina Elena Institute has access to all standard staining and antibodies for immunohistochemistry analysis, such as 34betaE12, P504S and racemase for prostate cancer, cytokeratin 7 e 20 for urothelial cancer, vimentin, CD10 and PAX 8 for kidney cancer, CD30 alpha-fetoprotein, PLAP and Podoplanin for testicular cancer, etc.) and follows Standard Operating Procedures according to the NCI standards.


The NCI has no knowledge of any other laboratory having access to these biospecimens. The proposed source is uniquely experienced in performing all of the technical requirements of the Statement of Work. The DCEG has used this proposed source with their specific methods and specimen access related to their scientific investigations. The DCEG's scientific investigation is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of the stated investigation. A change would be disruptive to the ability to analyze DCEG's cumulative results.


This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a capability statement, proposal or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 5:00 PM EST, on January 22, 2017. All responses and questions must be submitted via email to Kathy Elliott, Contracting Specialist at Elliottk@mail.nih.gov. 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, contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through sam.gov. Reference: N02CP72513-61 on all correspondence.


KATHY D. ELLIOTT, Contract Specialist, Phone 240-276-5570, Fax 240-276-5401, Email ELLIOTTK@MAIL.NIH.GOV - Catherine Muir, Contracting Officer, Phone (301) 435-3779, Fax (301) 402-6699, Email muirca@mail.nih.gov

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