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Pragmatic randomized trial of polygenic risk scoring for common diseases in primary care

Award Number: R35HG010706
ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/14/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Pragmatic randomized trial of polygenic risk scoring for common diseases in primary care - PROJECT SUMMARY (unchanged from currently approved project) In this project, we will develop and validate clinical polygenic risk scores (PRS) for six common diseases: coronary artery disease, atrial fibrillation, type 2 diabetes mellitus, breast cancer, colorectal cancer, and prostate cancer. This test will then be used in a point-of-care pragmatic randomized controlled trial of PRS testing and linked clinical recommendations compared to usual care (UC). Enrolled patients without a known diagnosis of any of the six target diseases will undergo clinical PRS genotyping. Patients with at least one PRS indicating high risk (odds ratio, ORPRS, ≥2.0) will be randomized to have them and their primary care provider receive their high-PRS results at baseline (PRS arm) or after a 24-month observation period (UC arm), reported along with evidence-based screening and management recommendations. Patients will be observed for 24 months for the primary clinical outcome of time-to-diagnosis of any one of the 6 target diseases. Secondary clinical outcomes will include changes in clinical management and patient health behaviors. Enrolled patients with all ORPRS<2.0 will be observed as concurrent controls for the same outcomes. Additional implementation outcomes will be collected over the course of the study, including provider knowledge and beliefs about PRS, patient activation, medication adherence, and costs.


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 = $255,000 )
2024	2024	BOSTON VA RESEARCH INSTITUTE, INC.	2 AVENUE DE LAFAYETTE	BOSTON	MA	02111	SUFFOLK	USA	Human Genome Research	001	5	9/18/2024	SUPPLEMENT FOR EXPANSION	$255,000
2024	2023	BOSTON VA RESEARCH INSTITUTE, INC.	2 AVENUE DE LAFAYETTE	BOSTON	MA	02111	SUFFOLK	USA	Human Genome Research	000	5	6/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $255,000

Issue Date FY: 2023 ( Subtotal = $584,821 )
2023	2023	BOSTON VA RESEARCH INSTITUTE, INC.	150 S HUNTINGTON AVE # 151B	BOSTON	MA	02130	SUFFOLK	USA	Human Genome Research	002	4	12/8/2022	SUPPLEMENT FOR EXPANSION	$90,786
2023	2023	BOSTON VA RESEARCH INSTITUTE, INC.	150 S HUNTINGTON AVE	BOSTON	MA	02130	SUFFOLK	USA	Human Genome Research	003	5	7/6/2023	NON-COMPETING CONTINUATION	$494,035
2023	2022	BOSTON VA RESEARCH INSTITUTE, INC.	150 S HUNTINGTON AVE	BOSTON	MA	02130	SUFFOLK	USA	Human Genome Research	001	4	11/17/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$97,082
2023	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	000	3	11/17/2022	NON-COMPETING CONTINUATION	-$97,082
														Subtotal = $584,821

Issue Date FY: 2022 ( Subtotal = $388,500 )
2022	2022	BOSTON VA RESEARCH INSTITUTE, INC.	150 S HUNTINGTON AVE # 151B	BOSTON	MA	02130	SUFFOLK	USA	Human Genome Research	001	4	8/12/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$388,500
2022	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	000	3	2/8/2022	NON-COMPETING CONTINUATION	$0
2022	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	002	3	8/15/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $388,500

Issue Date FY: 2021 ( Subtotal = $386,100 )
2021	2021	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	000	3	8/11/2021	NON-COMPETING CONTINUATION	$386,100
														Subtotal = $386,100

Issue Date FY: 2020 ( Subtotal = $596,418 )
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	003	2	7/13/2020	SUPPLEMENT FOR EXPANSION	$210,318
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	004	2	8/3/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	002	2	6/17/2020	NON-COMPETING CONTINUATION	$386,100
2020	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	000	1	12/4/2019	NEW	$0
2020	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	001	1	6/10/2020	NEW	$0
														Subtotal = $596,418

Issue Date FY: 2019 ( Subtotal = $386,100 )
2019	2019	PRESIDENT AND FELLOWS OF HARVARD COLLEGE	25 SHATTUCK ST	BOSTON	MA	02115	SUFFOLK	USA	Human Genome Research	000	1	8/27/2019	NEW	$386,100
														Subtotal = $386,100

Grand Total All Awards = $2,596,939

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Pragmatic randomized trial of polygenic risk scoring for common diseases in primary care

Award Number: R35HG010706

ORGANIZATION: NATIONAL HUMAN GENOME RESEARCH INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/14/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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