U01CA271888

Clinical Validation Center for Lung Cancer Early Detection - Abstract

The Lung Cancer Early Detection Clinical Validation Center (CVC) has two main goals. Specific Aim 1 aims to develop a blood-based biomarker panel for personalized risk assessment, with a focus on cost-effectiveness. Extensive validation work has been conducted in Phase 3 studies using retrospective longitudinal cohorts to test the performance of a four-marker protein panel (4MP) in determining lung cancer risk and the need for CT screening. Moving forward, the goal is to test the 4MP alone and in combination with other types of markers in the screening setting, using lung cancer screening cohorts available to the CVC. The resulting marker panel, combined with subject characteristics, would identify subjects who are currently not eligible for CT screening based on USPSTF criteria but would benefit from it based on their risk. This would ultimately lead to a utility trial, for which a concept has been presented at a recent EDRN scientific meeting. The utility trial concept also includes the objective of testing the value of biomarkers in informing subjects who are currently eligible but undecided about undergoing CT screening, about their risk through a decision-sharing process.

Specific Aim 2 will test the use of biomarkers and artificial intelligence (AI) for the interpretation of CT images and to personalize the screening frequency and duration. Sub Aim 1 aims to validate the previously developed biomarker of the macrovasculature surrounding a nodule (vessel number) in an independent screening cohort. Sub Aim 2 aims to develop a validated integrative computational model for improved early lung cancer detection. This model will include blood-based biomarkers, CT features such as emphysema, the presence or absence of a nodule, small airways, and subject characteristics for the interpretation of CT images and to determine screening frequency. The model will undergo a cost-effectiveness analysis compared to current lung cancer screening guidelines.

The CVC represents a multi-institution, multi-investigator effort with expertise in cancer biomarkers and statistics, pulmonology and lung cancer, epidemiology, radiomics, bioinformatics and artificial intelligence, and clinical trial design, simulation modeling, and cost-effectiveness analysis. The CVC has substantial accomplishments in biomarker discovery and validation related to lung cancer screening and in CT image analysis. In pursuit of its aims, the CVC has access to samples from a multitude of cohorts for validation studies.

The Univeristy Of Texas M.D. Anderson Cancer Center

TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.394 - Cancer Detection and Diagnosis Research

National Cancer Institute (NCI) [HHS - NIH]

Houston, Texas 770304009 United States

Single Zip Code

The Early Detection Research Network: Clinical Validation Centers (U01 Clinical Trial Optional) (RFA-CA-21-033)

Amendment Since initial award the total obligations have increased 516% from $792,272 to $4,880,009.