Feasibility Study for Cancer Information and bio-specimen collections in the French DM-Scope Registry

General Information Short Title: Feasibility Study for Cancer Information and bio-specimen collections in the French DM-Scope Registry Document Type: Presolicitation Notice Solicitation Number: N02CP72600-36(A) Posted Date: 6/21/2017 Response Date: 6/26/2017 Classification Code: AJ51 - R&D Life Sciences - Basic Research NAICS Code: 541711 - Research and Development in Biotechnology Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Description Myotonic dystrophy (DM) is a rare autosomal dominant multisystem disease primarily affecting skeletal muscles. Using data from the Swedish and Danish population registries, NCI investigators showed that cancer is part of the DM-phenotypes, with specific excess risks of cancers of the endometrium, ovary, brain, and colon. Our work was followed by few small mostly clinic-based studies that replicated the overall excess risk, but inconsistency in specific excess risk by cancer sites was noted. The observed inconsistency related to cancer sites across studies hinders patient comprehensive care and scientific interest to understanding the molecular basis of this observation. To move the field forward, large population-based study of genetically confirmed DM patient and biospecimen collection are needed. The French DM-Scope Registry provides this opportunity since it is the largest DM registry that systematically collects clinical information on more than 2000 French DM patients. In this project, NCI investigators will collect cancer information and blood samples from a subset of ~300 patients from the registry, and retrieve tumor tissue blocks and pathology report from treating center. Because of the large scope of such effort, this procurement is a feasibility study to assess measures of success of a larger effort aiming at the entire registry population. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541711 and the business size standard is 1000 employees. 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 from July 15, 2017 through July 14, 2018. It has been determined there are no opportunities to acquire green products or services for this procurement. The purpose of the current procurement is to test the feasibility of a large scale data and biospecimen collection study from DM patients enrolled in the DM-Scope Registry. The Contractor shall perform the following tasks: 1. Identify neuromuscular centers with prevalent DM patients to carry this study. We expect at least 300 patients in this study. 2. Using patient medical records, collect cancer history information to all DM patients included in the study 3. Link this information to available patient demographics, genetic, and clinical data available in the registry 4. De-identify patient information from developed datafile, create a new code that will be used to link patient data and samples, and send datafile to NCI 5. Complete IRB and institutional requirements to allow for patient contact 6. Invite survivors to participate in biospecimen collection. 7. Arrange for blood collection, samples preparation, and shipment to NCI 8. For patients with cancer, retrieve tumor tissue samples (blocks, slides, and/or frozen tissue) and ship them to NCI. Use the new created patient code to allow for linking the samples with patient information 9. Send a de-identified copy of patient pathology report with tumor specimen. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, 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 12:00 PM EST, on June 26, 2017. All responses and questions must be in writing and faxed +1 (555) 000-0000 or emailed to David Romley, Contract Specialist OR via electronic mail at contact@example.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 certification in the System for Award Management (SAM) through sam.gov. Reference: N02CP72600-36(A) on all correspondence.