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BACKGROUND:

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) is conducting the Sherlock lung project, a large study of lung cancer in never smokers. Lung cancer in never smokers includes approximately 10-25% of all lung cancers worldwide, ranks among the most common causes of cancer mortality, and has a distinct natural history, restricted histological subtype (almost exclusively adenocarcinoma), likely different profile of oncogenic mutations, and response to targeted therapy compared to lung cancer in smokers. Although a few risk factors are known to contribute to the etiology of lung cancer in never smokers, a large fraction of cancer cases cannot be explained by established environmental and genetic risk factors, highlighting the need for research in this area. One promising approach to identify the etiological factors involved in lung tumorigenesis in never smokers is based on the study of the "mutational signatures" that the exogeneous and endogenous processes leave on the tumor tissue and surrounding areas. This approach has identified over 50 different mutational signatures in other cancer types to date, corresponding to several oncogenic processes.

The primary goals of the Sherlock lung study are: (1) to identify mutational signatures of the endogenous and exogenous processes involved in lung tumorigenesis and order them along the lung tumor evolutionary trajectory, and (2) to develop an integrated molecular, histological and radiological classification of lung cancer in never smokers. Investigators will conduct an integrative genomic analysis of mutational signatures in tumors and surrounding non-tumor ("normal") lung tissue from 2,000 never smokers. The cases will include a subset of "special exposure cases" exposed to high levels of known risk factors for lung cancer (n=~500) and cases from the "general population" without known risk factors (n=~1,500). Cases from many geographical areas and ethnic groups will be included to study the contribution of different germline and environmental factors. The tumor/normal genomics analysis will include whole genome sequencing, RNA sequencing, and genome-wide methylation arrays. The integrated molecular landscape will be ordered along the evolutionary trajectory of the tumors to infer the cascade of events leading to tumor formation and progression. Data on the molecular and evolutionary landscape will be combined with data from the histological examination of H&E slides from multiple tissue blocks per tumor and related to CT-scan imaging to provide a more refined classification of lung cancers among never smokers. Additional analyses for subsets of the cases will include liquid biopsy, tumor microenvironment, clonal evolution, and mining of electronic medical records and national databases to look for associations with other medical conditions and chronic medications. This comprehensive research program will contribute to the understanding of the etiology and progression of lung cancer in never smokers and will provide clues into prognosis and treatment strategies.

OBJECTIVE:

Sherlock lung investigators are seeking external scientific input regarding the conduct and analysis of Sherlock lung, particularly with regard to analytic approaches and the development of novel methods, tools, and techniques for analyzing genomic data and studying clonal evolution and lung cancer heterogeneity. This type of specific expertise is necessary for the successful implementation and completion of the project.

REQUIREMENTS:

The Contractor shall:

• Participate in email exchanges and weekly video-conference calls with the Sherlock lung Principal Investigator, to provide scientific input related to analytic approaches for the Sherlock lung project, including the development of novel analytic and sequencing methods, tools, and techniques for genomic analyses.
• Assist the NCI Team with conducting and interpreting genomic analyses for 2,500 cases of lung cancer in never-smokers for Sherlock lung.
• Participate in Sherlock lung writing teams and manuscript preparation by providing input to the NCI team on manuscript content and drafts. Input will be provided by email and during video-conference calls.
• Attend two events per performance period at the National Cancer Institute (NCI) 9609 Medical Center Drive, Rockville, Maryland 20850. During these visits, the Contractor will be expected to attend full-day in-person meetings and provide input into topics such as study design, analytic methods, tools, and techniques, data analysis and interpretation, and manuscript preparation.

DELIVERABLES AND DELIVERY SCHEDULE:

• Ongoing weekly video-conference calls with the Sherlock lung PI
• Ongoing written advice and input as requested on Sherlock lung study design, conduct, analysis, and study documents
• Ongoing development of analytic tools and methods for genomic analyses
• Ongoing interpretation of Sherlock lung genomic analyses
• Ongoing participation in Sherlock lung manuscript preparation
• Two trips per performance period to the National Cancer Institute (NCI) 9609 Medical Center Drive, Rockville, Maryland 20850

PERIOD OF PERFORMANCE:

The period of performance shall be for a 12-month base period with two (2) 12-month option periods.

PLACE OF PERFORMANCE:

All work shall be performed at the Contractor's facility except for in-person collaborations during Contractor visits to NIH, which will occur two times per performance period. The location of in-person visits will be:

National Cancer Institute (NCI)
9609 Medical Center Drive
Rockville, Maryland, 20850.

DELIVERY POINT:

All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and should be emailed to Adam Hernandez, Contract Specialist at [email protected] by no later than March 8, 2019 by 4:00 PM EST. A determination by the Government not to compete this 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. In order to receive an award, contractors must have valid registration and certification in the System for Awards Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference number 75N91019Q00035 on all correspondence.

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