U2CCA271891

A Multidisciplinary BCC for Ovarian Cancer Early Detection: Translating Discoveries to Clinical Use with a By-Design Approach - Project Summary (Overall)

High-grade serous ovarian carcinoma (HGSOC) is the most common histological subtype of epithelial ovarian cancer. The overarching goal of the proposed Biomarker Characterization Center (BCC) is to apply a by-design approach based on biology of HGSOC pathogenesis and unmet clinical needs to identify, verify and prioritize, and validate biomarkers, and to develop them into an in vitro diagnostic multivariate index assay (IVDMIA) with the intended use to capture HGSOC in high-risk women at the early stages including i) precursors, ii) confinement to the ovary/fallopian tube or iii) low-volume diseases in high-risk women (BRCA1/2 carriers).

The biomarkers that we propose to discover and validate in this proposal are intended for early detection but not necessarily for screening in general population. The BCC’s capability in advanced data generation technologies, multiplexed target assay development, and bioinformatics/data science will serve as resources for the EDRN.

Based on the success of our current EDRN projects, this BCC will continue our ongoing biomarker development studies including the validation of candidate biomarkers that we have identified through the current BDL. We propose the following specific aims:

1. To optimize and use novel specimen collection and processing technologies, and an iterative and cumulative process that takes advantage of our newly gained knowledge of the biology in ovarian cancer pathogenesis. BDL

2. To optimize and apply innovative bioinformatics, data sciences, and AI/ML tools that incorporate existing knowledge and data to improve discovery of low frequency biomarkers that with their functionally shared pathways/networks could collectively deliver an improved sensitivity while retaining a high specificity. BDL

3. To further develop and optimize the process for efficient multiplex targeted assay development with respect to analytical performance, throughput, and specimen volume requirement for a broad spectrum of candidate biomarkers using a “fit for purpose” approach. BRL

4. To optimize and apply a by-design approach to translating discoveries into clinical tests. Its application had been critical in the development of two FDA cleared tests by JHU team members for the preoperative assessment of ovarian malignancy risk. BDL/BRL

5. To provide expertise and analytical and data science capabilities to the entire EDRN community. The multi-disciplinary team that we have assembled (molecular cancer biology, pathology, clinical chemistry, mass spectrometry, biostatistics, data science, bioengineering), the unique, novel yet biologically and statistically sound approaches, and our long-standing experience in biomarker research and translating discoveries to FDA cleared clinical tests all together ensure the success of this proposed BCC.

The Johns Hopkins 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]

Baltimore, Maryland 212182608 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 355% from $679,873 to $3,094,498.