U2CCA271898

The Boston University - UCLA Lung Cancer Biomarker Characterization Center - Abstract Screen and Incidentally Detected Intermediate Risk Indeterminate Pulmonary Nodules (IPN) represent a clinical dilemma for which there is little consensus about appropriate follow-up due to a lack of sensitive and specific approaches for the detection of lung cancer absent invasive tissue sampling, and concerns about costs and harms from invasive tissue sampling in this large clinical population.

Minimally invasive approaches that could accurately reclassify individuals from the intermediate risk group (5-65% risk of malignancy) to either low (< 5%) or high (>65%) risk would reduce uncertainty and transform the diagnostic workup of intermediate risk IPN. Developing, evaluating, standardizing, and validating such minimally invasive biomarkers so that they are ready for clinical use is the goal of the proposed BU-UCLA Lung Cancer Biomarker Characterization Center (BCC).

In previous EDRN-funded work, we established lung-cancer associated gene expression patterns in nasal epithelium collected with a swab from the inferior turbinate as a lung cancer biomarker. A test based on this innovative approach to lung cancer detection is being launched for clinical use as a CLIA LDT by our long-time collaborator Veracyte, Inc., which is participating in this BCC. We will evaluate the nasal biomarker for lung cancer in the setting of intermediate risk IPN.

To further improve the ability to clinically discriminate benign from malignant intermediate risk IPN, the BU-UCLA Lung Cancer Biomarker Discovery Lab embedded within the BCC will develop and test lung cancer detection approaches that incorporate detection of circulating tumor cells (CTC) using a CLIA LDT assay from our collaborator LungLife AI, Inc., as well as blood-based immune biomarkers, advanced imaging biomarkers, and refined nasal gene expression biomarkers. We will additionally determine if longitudinal biomarker assessment improves lung cancer detection over cross-sectional measurements.

Promising assays will be refined, standardized, and validated by the BU-UCLA Lung Cancer Biomarker Reference Lab embedded within the BCC to advance them toward clinical adoption. These studies are enabled by biospecimens and imaging data that are being prospectively collected from diverse populations of patients undergoing workup for intermediate risk IPN in several large-scale ongoing clinical studies including VA LPOP, DECAMP 1-PLUS, and UCLA IDX; lung cancer research programs at UCLA and Lahey; and our EDRN collaborators at Nashville VA and Vanderbilt.

The BU-UCLA Lung Cancer BCC team has the required multi-disciplinary expertise in lung cancer, translational and clinical pulmonary medicine, biomarker discovery, clinical assay development, biostatistics, clinical epidemiology, pathology, imaging, artificial intelligence, biological sciences, bioinformatics, genomics, and complex scientific program management to accomplish these goals.

An administrative core embedded within the BCC will ensure that the BCC delivers on its aim to substantially advance novel lung cancer biomarkers from discovery to clinical application and make significant contributions to the Early Detection Research Network.

Trustees Of Boston University

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]

Boston, Massachusetts 021182657 United States

Single Zip Code

The Early Detection Research Network: Biomarker Characterization Centers (U2C Clinical Trial Not Allowed) (RFA-CA-21-035)

Amendment Since initial award the total obligations have increased 392% from $718,649 to $3,536,715.