Request for Information (RFI): US Pediatric Photon Therapy Comparison Cohort Study

General Information: This Request for Information (RFI) is the purpose of providing source material to assist in formulating a procurement strategy for obtaining data for photon treated pediatric cancer patient. This RFI should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health (NIH), and the National Cancer Institute (NCI). The Government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited. Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal. This RFIis issued for the purpose of providing source material to assist in formulating a procurement strategy for obtaining data for photon treated pediatric cancer patients. Purpose: The responses to this RFI may guide the NCI in awarding future contracts at an undetermined time. There is no solicitation available at this time; no basis for claims against NCI shall arise as a result of this RFI, responses thereto or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. This notice is for market research only. The NCI is specifically interested in determining the types of organizations available in the marketplace that provide these services and technologies. NAICS Code and Size Standard: In the event a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541990- All Other Professional, Scientific and Technical Services with a size standard of $15M is being considered. Background: The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. REB has a specific interest in the risk of second tumors following proton therapy in children, because the concern has been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors. NCI's primary aim is to add a comparison group of photon patients in order to quantify the subsequent cancer risks after proton compared to photon therapy. Subsequent cancers are one of the most common and serious adverse-effects of pediatric radiotherapy. Pediatric cancer is rare and therefore in order to assemble a comparison cohort of photon treated pediatric patients of adequate size, multiple pediatric treatment centers need to be recruited. No single center will likely have enough patients for the entire comparison cohort of 1000 or more patients. The contractor(s) shall provide a cohort of photon-treated pediatric cancer patients with detailed clinical and treatment data to serve as a comparison group for the evaluation of the risks and benefits of proton therapy for children. The contractor(s) shall select photon treated pediatric cancer patients for inclusion in the comparison cohort and collect required medical record and radiotherapy and imaging data from photon-treated pediatric cancer patients and upload the de-identified data to online data platforms (REDCap and MIM) maintained by the Pediatric Proton/Photon Consortium Registry (PPCR). Anticipated activities performed by the hospital center(s) include: 1. Study Subject Identification a) Select study subjects (photon-treated pediatric cancer patients), who were less than 22 years of age at diagnosis and treated with photons since 2006, for enrollment in the Pediatric Proton/Photon Consortium Registry (PPCR). b) Compile a roster of eligible study subjects at each study center. Study subjects shall be identified retrospectively of receiving treatment. c) Obtain all necessary IRB approvals in order to abstract clinical and treatment details for photon-treated pediatric cancer. 2. Data Collection a) Work with the PPCR in order to have a study ID assigned to each eligible study subject and obtain permission to upload de-identified abstracted data to REDCap. b) Abstract diagnosis and treatment data from medical records. Data elements to be abstracted are provided in the study protocol provided by NCI. c) Upload de-identified abstracted diagnosis and treatment data for the study subjects to REDCap. d) Verify a sample of 5% of abstracts by independent re-abstraction in order to provide quality control of the data abstraction. Provide documentation of the outcome of the re-abstraction to the PPCR. e) Obtain copies of de-identified photon diagnostic imaging and final treatment plans that may include CT structure, radiation treatment plan and dose files, and follow-up radiologic imaging studies as available for review by the PPCR dosimetrist. Assist the dosimetrist to unarchive original treatment plans, if needed. Information Requested: 1. Are there hospital centers with data for photon treated pediatric cancer patients treated in 2006 or later that are able and willing to serve as a coordinating center for other hospital centers to provide data to the PPCR? 2. Are the hospital center(s) with photon treated pediatric cancer patients willing to share their photon data with the PPCR through the online data platforms REDCap and MIMS systems? In addition, the NCI seeks information regarding the following four (4) questions. Please provide a "YES" or a "NO" response. Item Indicator 1. Would your organization be able to provide the following capabilities? 2. Have you served as a coordinating center for at least three (3) projects where you have worked with multiple teams from various hospitals? 3. Have you successfully coordinated and managed the integration of data from various centers? 4. Are you willing to share your data for pediatric cancer patients treated with photons with the NCI and its collaborators? How to Submit a Response: Interested organizations should submit a response to this Request for Information, not to exceed 10 single sided pages including all attachments, charts, etc. (single space, 12-point font minimum) that clearly responds to the above questions. Brevity and structured format (such as bulleted items) are encouraged whenever applicable to aid in processing. All proprietary information should be marked as such. Responses will be held in a confidential manner. NCI will provide confirmation of response submission, but respondent will not receive individualized feedback. Due Date: Responses are due no later than 3PM Eastern Time on December 2, 2019. Number of Copies and Delivery Point: Please submit your response to Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov . All information furnished must be in writing. All questions must be in writing and emailed to Lisa, Contracting Officer, at lisa.bielen@nih.gov. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Please reference number HHS-NIH-NCI-RFI-ETSB-0008-4 on all correspondence. Point of Contact: Inquiries concerning this Notice may be directed to: Lisa Bielen 9609 Medical Center Drive Bethesda, MD 20892 lisa.bielen@nih.gov