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Biomarkers for optimizing risk prediction and early detection of cancers of the colon and esophagus

Award Number: U2CCA271902
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/05/2022
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	3	3/11/2025	NON-COMPETING CONTINUATION	$0
2025	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	3	4/11/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $864,543 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	003	3	8/9/2024	NON-COMPETING CONTINUATION	$864,543
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	2	3/14/2024	NON-COMPETING CONTINUATION	$0
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	2	7/2/2024	NON-COMPETING CONTINUATION	$0
2024	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	2	10/23/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $864,543

Issue Date FY: 2023 ( Subtotal = $1,009,158 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	2	7/7/2023	NON-COMPETING CONTINUATION	$1,009,158
														Subtotal = $1,009,158

Issue Date FY: 2022 ( Subtotal = $739,072 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	1	8/5/2022	NEW	$739,072
														Subtotal = $739,072

Grand Total All Awards = $2,612,773

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Biomarkers for optimizing risk prediction and early detection of cancers of the colon and esophagus

Award Number: U2CCA271902

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/05/2022

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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