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Fred Hutchinson Breast Cancer Clinical Validation Center

Award Number: U01CA152637
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/16/2010
PERIOD OF PERFORMANCE END DATE: 07/31/2027

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Fred Hutchinson Breast Cancer Clinical Validation Center - ABSTRACT There remain clear clinical and public health needs to improve the early detection of breast cancer. While mammography is an effective tool, there are issues with respect to optimizing its use and performance, and despite widespread screening breast cancer remains the 2nd most common cause of cancer related death among U.S. women. Through the current EDRN Clinical Validation Center (CVC) led by Dr. Li we have validated 15 candidate biomarkers through a series of Phase 2 and Phase 3 validation studies that involved successive series of three independent sets of preclinical samples. Outside of EDRN funding, Dr. Partridge has led the development of novel strategies to improve breast cancer detection based on quantitative markers derived from screening MRIs in high-risk women and application of artificial intelligence (AI) approaches in collaboration with Microsoft. Our overarching goal is to conduct Phase 2 and 3 validation studies of blood- based biomarkers and imaging strategies that will be integrated and jointly assessed in a Phase 4 validation study. Supporting this goal we propose the following 4 projects: Project 1: Phase 3 validation of early detection biomarkers for ER+ breast cancer; Project 2: Phase 2 and 3 validation of protein biomarkers for the early detection of breast cancer discovered using a mass spectrometry-based platform; Project 3: Phase 3 validation of quantitative markers and AI algorithms applied to MRI screening exams for the early detection of breast cancer in women at high risk; and Project 4: Phase 4 validation of blood-based biomarkers and imaging algorithms for the early detection of breast cancer. Additionally, we will provide biospecimens and expertise to support high quality PRoBE compliant EDRN discovery and validation studies across several cancer types. With the combined expertise of our multidisciplinary team of investigators and our engagement with key commercial partners, this CVC will both lead well-justified, rigorously designed validation studies and provide abundant resources to EDRN. Given the strength of our biomarker candidates, the sets of biospecimens that will be used, the study designs employed, and the clearly delineated clinical applications proposed, we anticipate that this work will yield near-term clinical impact.


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: 2024 ( Subtotal = $1,047,995 )
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	14	7/29/2024	NON-COMPETING CONTINUATION	$1,047,995
2024	2024	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	14	9/11/2024	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	13	10/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,047,995

Issue Date FY: 2023 ( Subtotal = $1,060,017 )
2023	2023	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	004	13	6/26/2023	NON-COMPETING CONTINUATION	$1,060,017
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	003	12	5/23/2023	COMPETING CONTINUATION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	12	5/11/2023	COMPETING CONTINUATION	$0
2023	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	12	5/19/2023	COMPETING CONTINUATION	$34,283
2023	2020	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	11	5/19/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$34,283
														Subtotal = $1,060,017

Issue Date FY: 2022 ( Subtotal = $807,303 )
2022	2022	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	007	12	8/3/2022	COMPETING CONTINUATION	$807,303
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	005	10	7/12/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	10	6/8/2022	SUPPLEMENT FOR EXPANSION	-$166,534
2022	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	008	10	8/4/2022	SUPPLEMENT FOR EXPANSION	-$24,089
2022	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	004	10	7/12/2022	NON-COMPETING CONTINUATION	$0
2022	2020	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	009	11	8/4/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$24,089
2022	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	10	3/4/2022	NON-COMPETING CONTINUATION	$0
2022	2020	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	006	11	7/27/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2022	2020	FRED HUTCHINSON CANCER CENTER	1100 FAIRVIEW AVE N	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	003	11	6/8/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$166,534
2022	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	10	6/8/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $807,303

Issue Date FY: 2021 ( Subtotal = $585,487 )
2021	2021	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	10	4/7/2021	SUPPLEMENT FOR EXPANSION	$585,487
2021	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	10	11/25/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $585,487

Issue Date FY: 2020 ( Subtotal = $836,410 )
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	10	9/3/2020	NON-COMPETING CONTINUATION	$0
2020	2020	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	10	3/31/2020	NON-COMPETING CONTINUATION	$836,410
2020	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	9	3/31/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $836,410

Issue Date FY: 2019 ( Subtotal = $779,890 )
2019	2019	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	9	4/24/2019	NON-COMPETING CONTINUATION	$779,890
														Subtotal = $779,890

Issue Date FY: 2018 ( Subtotal = $1,085,901 )
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	8	6/12/2018	NON-COMPETING CONTINUATION	$441,373
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	8	3/29/2018	NON-COMPETING CONTINUATION	$531,499
2018	2018	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	8	8/29/2018	NON-COMPETING CONTINUATION	$113,029
														Subtotal = $1,085,901

Issue Date FY: 2017 ( Subtotal = $1,011,816 )
2017	2017	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	7	3/9/2017	NON-COMPETING CONTINUATION	$875,583
2017	2017	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	7	6/7/2017	NON-COMPETING CONTINUATION	$97,287
2017	2016	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE N J6-300	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	6	7/7/2017	COMPETING CONTINUATION	$38,946
														Subtotal = $1,011,816

Issue Date FY: 2016 ( Subtotal = $1,011,430 )
2016	2016	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	6	5/4/2016	COMPETING CONTINUATION	$972,485
2016	2016	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	001	6	9/8/2016	COMPETING CONTINUATION	$38,945
														Subtotal = $1,011,430

Issue Date FY: 2015 ( Subtotal = $93,620 )
2015	2015	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	5	9/14/2015	SUPPLEMENT FOR EXPANSION	$93,620
														Subtotal = $93,620

Issue Date FY: 2014 ( Subtotal = $725,717 )
2014	2014	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	5	8/6/2014	NON-COMPETING CONTINUATION	$725,717
														Subtotal = $725,717

Issue Date FY: 2013 ( Subtotal = $1,046,464 )
2013	2013	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	000	4	6/25/2013	NON-COMPETING CONTINUATION	$881,335
2013	2013	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Trans-NIH Research Support	001	4	9/12/2013	SUPPLEMENT FOR EXPANSION	$165,129
														Subtotal = $1,046,464

Issue Date FY: 2012 ( Subtotal = $976,499 ) (Continued on the next page)
2012	2012	FRED HUTCHINSON CANCER RESEARCH CENTER	1100 FAIRVIEW AVE NO J6-330	SEATTLE	WA	98109	KING	USA	Cancer Detection and Diagnosis Research	002	3	9/24/2012	NON-COMPETING CONTINUATION	$191,583
Grand Total All Awards = $12,722,762

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Fred Hutchinson Breast Cancer Clinical Validation Center

Award Number: U01CA152637

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/16/2010

PERIOD OF PERFORMANCE END DATE: 07/31/2027

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