Support for subject matter expertise in Cancer Surveillance Activities

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive Room 1E154 Bethesda, MD 20892 Description: The National Cancer Institute (NCI), Epidemiology and Genomics Research Program (EGRB), Clinical and Translational Epidemiology Branch (CTEP) plans to procure on a sole source basis with Emory University for subject matter expertise in epidemiology, polygenic risk prediction, statistical modeling, model validation and evaluation, cost-benefit analysis and cancer screening programs.. The products herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 611310 and the small business standard is $25.5 million dollars. Only one (1) award will be made as a result of this solicitation. This will be awarded as a Firm Fixed Price (FFP) contract. It has been determined there are no opportunities to acquire green products or services for this procurement. The CTEP has a project that requires subject matter expertise in epidemiology, polygenic risk prediction, statistical modeling, model validation and evaluation, cost-benefit analysis and cancer screening programs. Genome-wide association studies have identified common genetic variants associated with common cancers, including colorectal cancer, breast cancer, prostate cancer, lung cancer and esophageal cancer. These variants can be combined to create polygenic models, through which the additive effects of genes, along with environmental determinants, create a normal distribution of disease risk in the population. Polygenic models and polygenic inheritance lead to low individual risk prediction. However, it is unclear if polygenic models could be useful as risk stratifiers in population screening to target population subgroups at high risk and reduce screening in population subgroups at low risk. An evidence-based approach is needed to elucidate the extent to which genetic variants can improve risk prediction for common cancers. Specifically, there is a need for empirical, as well as modeled evidence of the effectiveness of risk stratified analysis. Items needed to help fill this current evidence gap include: a) the development of models that provide guiding principles for the discriminatory ability (measured as Area Under the Curve: AUC) needed for risk stratification using polygenic models to be more effective than average-risk, or age stratified screening guidelines; b) validation of these models, and demonstration of their use in evaluating different screening strategies; and c) increased education of cancer intervention modelers on the role of polygenic inheritance in risk prediction and risk stratified screening. Contractor Requirements: The contractor shall provide adequate and appropriate staff, equipment, supplies, facilities, and scientific materials necessary for carrying out the requirements of this SOW. This project shall involve the expansion, modification and validation of PredictABEL (European Journal of Epidemiology, 2011, issue 26, page 261) and other methods developed by Emory researchers to determine the AUC needed for effective polygenic models. These methods shall be applied to the Cancer Intervention and Surveillance Modeling Network (CISNET) micro-simulation model of the adenoma-carcinoma sequence for colorectal cancer (MISCAN) for model validation (Risk Analysis, 2012, Supplement 1, page S85). Two colorectal screening strategies shall be evaluated and compared: one focusing only on identifying high risk individuals and a second focused on identifying both high and low risk individuals. The contractor shall meet with CISNET investigators at their annual meeting to describe their model and how it could be incorporated into current CISNET models for colorectal cancer and four other cancer types (breast, prostate, lung and esophageal). The contractor shall meet with CISNET investigators at their annual meeting to describe their model and how it could be incorporated into current CISNET models for colorectal cancer and four other cancer types (breast, prostate, lung and esophageal). Specifically, the tasks are: Task 1. Model of the discriminatory ability of polygenic models needed for risk stratified screening of cancer. The contractor shall revise and expand models developed by Emory researchers ("Emory models") in order to determine what level of AUC is needed for polygenic models to be more effective than unstratified screening for colorectal cancer. This will include an evaluation of metrics used to determine effectiveness of screening strategies (i.e. cost, number of lives saved per screen, number of quality life years gained). The contractor shall use the Emory models to consider two risk stratification programs for colorectal cancer. The first program shall consider using polygenic models to identify high risk individuals who should receive increased frequency of screening, with all other individuals receiving standard currently recommended screening. The second program shall use polygenic models to identify high risk individuals, as well as average risk individuals who should receive standard screening levels and low-risk individuals who should potentially receive less frequent screening. For each situation, the contractor shall provide model estimates of the level of AUC needed for the alternative screening strategies to be effective, compared with unstratified screening. The contractor shall compare the level of AUC needed and partial AUCs, as determined by their models, to current published estimates of the AUC for polygenic models in colorectal cancer, as well as to theoretical estimates of the maximum AUC for polygenic models of colorectal cancer. The focus of this task will be on colorectal cancer, and the contractor shall produce a standardized protocol detailing how this model could be extended to be applied to four other cancers (breast, lung, prostate and esophageal cancer). Task 2. Validation of methodologies using the models for CISNET colorectal cancer screening. The contractor shall determine how to translate the Emory models used in task 1 into appropriate inputs and parameters for modeling polygenic information in the CISNET MISCAN micro-simulation model. This shall include the creating of a table comparing the key assumptions made by each model. The contractor shall then use the CISNET MISCAN model to validate the results of the Emory models. Specifically, the MISCAN model shall also be used to evaluate the two alternative screening strategies (identification of a high risk group, and identification of high, average and low risk group) in comparison to unstratified screening. The results obtained using MISCAN microsimulation model will be compared with those predicted using the Emory models developed in Task 1. If the models do not agree, the contractor shall identify key aspects of the Emory models that need to be modified or recalibrated. The contractor shall produce a manuscript that describes the Emory models for colorectal cancer, including a description of the validation experiment using the CISNET MISCAN model and a description of the results for comparisons of different screening strategies. Task 3. Didactic presentations to the CISNET consortium on how to incorporate polygenic models into their cancer models. The contractor shall attend the colorectal cancer session of the CISNET 2013 Annual meeting, and present to all cancer groups at the plenary session of the CISNET 3013 Annual Meeting Rockville, MD December 3-4, 2013. CISNET models have served as a resource for US Preventative Services Task Force (USPSTF) evidence review panels as they revise screening recommendations for breast and colorectal cancers. Therefore, it is important to consider how polygenic risk stratification could best be incorporated and evaluated in CISNET models. The presentation should be viewed as an educational, rather than a purely scientific presentation. The goal shall be to review the motivation for polygenic modeling, current open questions in polygenic modeling and to detail the proposed models developed in Task 2. The presentation should also seek feedback to inform how CISNET models can best be used to validate the models for different cancers. The Emory models proposed were developed by people working at Emory University and no other site has access to modify these models. While some of the models (such as PredictABLE) have been published, others are still in development and are not yet publically available in the published literature. These specific models provide distinctive information needed to address the evidence gaps identified by NCI. Period of Performance: From September 24, 2013 to September 23, 2014. This is not a solicitation for competitive quotations. However, if any interested party, particularly small businesses, believe they can meet the above requirement, they may submit a statement of capabilities via fax or email. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. The capability statement must be received in the NCI contracting office on or before 4:00 PM EST on August 19, 2013. All questions must be in writing and can be faxed +1 (555) 000-0000 or emailed to Anh-Huy Nguyen, Contract Specialist at contact@example.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and certification in the System for Award Management (SAM) www.sam.gov. No collect calls will be accepted. Please reference solicitation number NCI-130092-HN on all correspondences.