R01CA257623

Fast-FNA Immune Cell Profiling in HNSCC

Currently, the single best predictive biomarker of response to anti-PD1 monotherapy is PD-L1 expression, as assessed by immunohistochemical staining of archived or fresh tissue. However, current workflows for PD-L1 assessment in tissue are labor and time-consuming, and can yield inconclusive results in a fraction of image-guided biopsies. Additionally, these workflows are associated with morbidity and are rarely performed serially.

Rapid on-site assessment of cellular specimens obtained through fine needle aspiration (FNA) could not only circumvent these bottlenecks but also enable more comprehensive and serial profiling of the tumor microenvironment. This would provide the most up-to-date information on a rapidly changing microenvironment during tumor evolution and therapy.

The goal of this project is to further develop and validate the new Fast-FNA technology for rapid biomarker discovery and validation in HNSCCs. There are two main aims:

Aim 1: Develop and validate existing and new biomarkers in FNA samples of HNSCC patients (N=100). Specifically, we will:
i) Develop and validate new predictive immunotherapeutic biomarkers.
ii) Determine how well the new Fast-FNA scores correlate with the CPS scores of PD-L1.

The goal of the second aim is to translate the above Fast-FNA technology to serial FNA analyses in HNSCC patients receiving anti-PD1 immunotherapy (with or without chemotherapy; N=100). FNA sampling will be performed pre- and on-treatment in order to capture changes in the tumor microenvironment.

As the HNSCC field shifts toward increased biomarker testing, there is an unmet clinical need to develop advanced cellular diagnostics in HNSCCs. These diagnostics will facilitate rapid biomarker analysis, guide therapies, and provide "real-time" assessment of clinical response.

The General Hospital Corporation

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]

Massachusetts United States

State-Wide

Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-19-056)

Amendment Since initial award the total obligations have increased 391% from $670,725 to $3,293,259.