US Pediatric Proton Therapy Study

Type of Notice: This is a Small Businesses Sources Sought notice (SBSS). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this project is 541990. The small business size standard is $15M. 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. The Branch has a specific interest in the risk of second tumors following proton therapy in children, because concern has been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors. Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, no studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about some serious unanticipated side-effects, such as brain necrosis. There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. NCI plans to create the first prospective cohort study by expanding the US Pediatric Proton Consortium Registry (PPCR) to add photon therapy centers and systematic follow-up. NCI's primary aim will be 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. The PPCR is the most practical place to start in the US, because it has been collecting data from the US proton centers for the past 7 years and has the infrastructure and knowledge in place for the study. This Small Business Sources Sought (SBSS) is for information and planning purposes only and shall not be construed as an obligation on the part of NCI. Purpose and Objectives: The goal of this acquisition is to obtain data on a group of photon-treated pediatric cancer patients to serve as a comparison group to an existing cohort of proton-treated pediatric patients. The objectives are to obtain and monitor data collection by individual hospital centers where pediatric cancer patients continue to be treated with photons in order to form a comparison cohort; provide access to the PPCR online data platforms (REDCap and MIM) for data collection and storage; and provide assistance to individual centers to collect required radiotherapy and imaging data to be comparable to the proton data in the PPCR. Project Requirements: The Contractor shall have experience managing a pediatric proton consortium registry including collecting clinical data from pediatric cancer patients treated with protons from multiple treatment centers and maintaining a database of clinical and treatment data. The Contractor shall perform the following tasks: 1. Obtain and monitor data acquisition for pediatric cancer patients treated at participating hospital centers that treat pediatric cancer patients with photons. This shall include travel to study sites to orient the participating study sites to the data requirements for the study that result in the collection of medical and radiotherapy treatment data. Follow-up travel to the participating centers will be on as needed basis to monitor study progress. NCI estimates up to ten trips will be needed. 2. Assign study participant IDs to all pediatric cancer photon-treated patients to facilitate creation of a cohort of photon-treated patients. 3. Monitor study subject enrollment and data collection progress through regular communication and occasional site visits with participating hospital centers. 4. Maintain the data acquisition and storage system in REDCaP, a secure web-based data collection platform with online survey capabilities, to house medical record data for a multi-center consortium registry for pediatric patients treated with protons. 5. Maintain a data storage system for radiotherapy plans and dose data in MIMS. 6. Provide access for the participating centers to enter data for photon patients into the PPCR REDCap data management system. 7. Monitor data regularly in REDCap for completeness across all participating sites. Provide participating sites with monthly reports identifying missing data fields that highlight the critical data fields. 8. Visit the study centers as needed to review archived and current radiotherapy plans. The contractor shall work closely with the participating centers, to collect final radiotherapy plans at participating hospital sites, including unarchiving older radiotherapy plans, and upload these plans into MIM for online central storage. 9. Monitor data regularly in MIM for completeness across all participating sites. Provide participating sites with monthly reports identifying missing treatment plans and other relevant radiation treatment data. Anticipated Period of Performance: The anticipated period of performance, inclusive of options, for this proposed acquisition is May 2020 - May 2022. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the aforementioned requirements and level of effort are to supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information furnished must not exceed 20 pages (12-point font minimum), including all attachments, resumes, charts, etc.; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Information Submission Instructions: NCI is seeking capability statements from all eligible small businesses concerns in performing the tasks/duties herein. Based on the responses received from this SBSS notice, the proposed project may be solicited as a Small Business Set-Aside. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Small Business Sources Sought notice or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement All capability statements sent in response to this Small Business Sources Sought notice must be sent electronically (via email) to Lisa Bielen, Contracting Officer at lisa.bielen@nih.gov and Jill Johnson, Contracting Officer at jill.johnson2@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by November 13, 2019; 2:00PM Eastern. All responses must be received by the specified due date and time in order to be considered. Capability Statements received after that date and time will not be considered. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation.