U2CCA271902

BIOMARKERS FOR OPTIMIZING RISK PREDICTION AND EARLY DETECTION OF CANCERS OF THE COLON AND ESOPHAGUS - PROJECT SUMMARY

GASTROINTESTINAL (GI) CANCERS ARE A MAJOR CAUSE OF MORTALITY AND MORBIDITY IN THE U.S. AND THEIR TREATMENT USES A SUBSTANTIAL PROPORTION OF HEALTHCARE RESOURCES.

OF THE GI CANCERS, COLORECTAL CANCER (CRC) AND ESOPHAGEAL CANCER (EAC) ACCOUNT FOR A MAJORITY OF THE CANCER RELATED DEATHS, AND BOTH ARE PREVENTABLE BY SCREENING AND SURVEILLANCE.

THE CURRENT SCREENING TESTS ARE SUBOPTIMAL AND HAVE VARIABLE SUCCESS. A MAJOR GOAL OF CRC SCREENING TESTS IS TO IDENTIFY ADVANCED TUBULAR AND SERRATED ADENOMAS, WHICH ARE HIGH-RISK FOR BECOMING CRC, AS WELL AS EARLY STAGE CRC.

THE RISK FOR CRC IS VARIABLE WITH SOME PEOPLE BEING AT HIGH RISK BECAUSE OF FAMILY HISTORIES OF CRC, HEREDITARY CANCER SYNDROMES, OR A PERSONAL HISTORY OF ADENOMAS. HIGH RISK PEOPLE ARE PLACED ON AGGRESSIVE COLONOSCOPY BASED SURVEILLANCE PROGRAMS AND LOW-RISK PEOPLE ARE PLACED ON MINIMAL SURVEILLANCE PROGRAMS.

UNFORTUNATELY, OUR CURRENT SYSTEM FOR IDENTIFYING HIGH AND LOW CRC RISK IS SUBOPTIMAL RESULTING IN UNDER AND OVER SURVEILLANCE AND PREVENTABLE INTERVAL CRCS. BETTER RISK MARKERS FOR CRC TO ARE NEEDED TO PREVENT INTERVAL CRCS AND IMPROVE THE OVERALL EFFECTIVENESS OF CRC SCREENING.

ANALOGOUS TO CRC, EAC ARISES FROM A PRECANCEROUS CONDITION OF THE ESOPHAGUS CALLED BARRETTS ESOPHAGUS (BE), WHICH IS A SPECIALIZED INTESTINAL METAPLASIA OF THE ESOPHAGUS AND THE HIGHEST RISK FACTOR FOR EAC. IT IS PRESENT IN 5% OF THE US POPULATION.

BE PROGRESSES TO EAC THROUGH SUCCESSIVE HISTOLOGIC STEPS OF LOW GRADE DYSPLASIA (LGD), HIGH GRADE DYSPLASIA (HGD) AND THEN EAC. SCREENING AND SURVEILLANCE FOR BE IS RECOMMENDED USING SERIAL UPPER ENDOSCOPY, WHICH IS CONTROVERSIAL IN ITS EFFECTIVENESS FOR PREVENTING DEATHS FROM EAC.

THIS IS IN PART BECAUSE, AS WITH CRC, BE PATIENTS HAVE VARIABLE RISK OF EAC AND ARE PLACED ON HIGH- RISK AND LOW-RISK SCREENING PROGRAMS. HOWEVER, THE CURRENT SYSTEM FOR ASSIGNING RISK IS NOT ACCURATE AND THE CURRENT SCREENING TEST IS EXPENSIVE.

MORE COST EFFECTIVE AND ACCURATE EAC AND HGD SCREENING/SURVEILLANCE ASSAYS AND ACCURATE BE RISK BIOMARKERS ARE NEEDED.

WE PROPOSE TO DEVELOP AN EDRN BCC THAT IS INTEGRATED INTO THE EDRN CONSORTIUM AND, THROUGH COLLABORATIONS WITHIN AND OUTSIDE THE EDRN, WILL DEVELOP EFFECTIVE GI CANCER SCREENING BIOMARKERS.

WE PROPOSE TO IDENTIFY, VALIDATE, AND DEVELOP ACCURATE CLIA COMPLIANT RISK BIOMARKERS FOR CRC AND FOR EAC IN ORDER TO PREVENT EAC AND CRC MISSED UNDER CURRENT SCREENING PROTOCOLS.

MOREOVER, THE ACCURATE RISK STRATIFICATION OF PATIENTS FOR CRC AND EAC WILL REDUCE THE FINANCIAL IMPACT OF CURRENT CRC AND EAC PREVENTION PROGRAMS.

WE ALSO PROPOSE TO IDENTIFY AND VALIDATE ACCURATE CLIA COMPLIANT EARLY DETECTION MARKERS FOR HGD AND EARLY STAGE EAC THAT CAN BE USED IN AN INEXPENSIVE, NON-ENDOSCOPIC SURVEILLANCE TEST.

Fred Hutchinson 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]

Seattle, Washington 981094433 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 393% from $739,072 to $3,642,526.