Thursday, May 22, 2025 5/22/2025

Prospective tReatment EffiCacy in IPF uSlng genOtype for Nac Selection (PRECISIONS) trial and Molecular Endophenotyping in Idiopathic Pulmonary Fibrosis and Interstitial Lung Diseases study

Award Number: U24HL145265
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

Group Awards By:

View Award Description

Prospective tReatment EffiCacy in IPF uSlng genOtype for Nac Selection (PRECISIONS) trial and Molecular Endophenotyping in Idiopathic Pulmonary Fibrosis and Interstitial Lung Diseases study - Despite being the most frequent and deadly of the interstitial lung diseases (ILD), Idiopathic Pulmonary Fibrosis (IPF) remains challenging to diagnose and treat. The diagnostic process for IPF relies on subjective interpretations of clinical data while current antifibrotic therapies employ a “one size fits all” paradigm. Our clinical collaborators have been at the forefront of developing `omics approaches to diagnose and define prognosis in ILDs. Importantly, they identified the first pharmacogenomic interaction suggesting that IPF patients with rs3750920 TOLLIP T/T genotype strongly benefited from use of N-Acetylcysteine (NAC). Our project leverages existing partnerships with the Pulmonary Fibrosis Foundation (PFF) Patient Registry and Biorepository studies. This group has recruited ILD patients who have provided extensive baseline phenotypic and longitudinal outcome data, biological samples and have consented to be re-contacted for future research. Our overall objectives are to 1) efficiently conduct a novel precision genotype-based IPF trial using PFF Clinical Care Network sites; and 2) molecularly characterize a broad range of ILDs and identify genetic variants associated with IPF risk. An experienced Data Coordinating Center (DCC) with strong statistical leadership and expertise is key in both design and analysis, particularly when unanticipated issues arise during the conduct of a clinical trial. The University of Michigan Statistical Analysis of Biomedical and Educational Research (SABER) unit in a top-ranked Department of Biostatistics will serve as DCC, bringing together an experienced group of faculty and staff in biostatistics, research design, project management, study monitoring, database design and data management, and research administration. SABER has a strong track record of collaborations with the participating pulmonary investigators in the Clinical Coordinating Center (CCC) and clinical sites. The overarching goal of the UM DCC is to collaborate with study investigators, the CCC, and NHLBI to enable successful achievement of the study on time and within budget. We will accomplish these goals through the three specific aims: (1) Enhance scientific rigor by providing statistical and clinical trials methodological expertise to design, analyze and disseminate research findings; (2) Ensure the collection of timely, accurate and reproducible data, and maximize adherence to the study protocol; and (3) Provide established infrastructure and services for study administration and operations and for communication among study stakeholders. Our leadership, experience, and expertise will promote collaborations, encourage scientific productivity, and facilitate timely dissemination of findings on “precision medicine era” IPF diagnosis, and benefits of a “precision” approach with a genotype-driven clinical trial.


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 = $418,479 )
2025	2025	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE STE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	001	6	3/26/2025	NON-COMPETING CONTINUATION	$367,279
2025	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	5	1/15/2025	NON-COMPETING CONTINUATION	$51,200
														Subtotal = $418,479

Issue Date FY: 2024 ( Subtotal = $576,006 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	5	4/9/2024	NON-COMPETING CONTINUATION	$576,006
														Subtotal = $576,006

Issue Date FY: 2023 ( Subtotal = $1,346,213 )
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	001	4	4/13/2023	NON-COMPETING CONTINUATION	$1,346,213
2023	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	3	3/4/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,346,213

Issue Date FY: 2022 ( Subtotal = $1,793,103 )
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	3	3/24/2022	NON-COMPETING CONTINUATION	$1,793,103
														Subtotal = $1,793,103

Issue Date FY: 2021 ( Subtotal = $1,875,962 )
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	001	2	4/6/2021	NON-COMPETING CONTINUATION	$1,539,962
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	002	2	8/26/2021	NON-COMPETING CONTINUATION	$336,000
2021	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	1	4/6/2021	NEW	$0
														Subtotal = $1,875,962

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	1	8/6/2020	NEW	$0
2020	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	001	1	9/18/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $582,305 )
2019	2019	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Lung Diseases Research	000	1	9/20/2019	NEW	$582,305
														Subtotal = $582,305

Grand Total All Awards = $6,592,068

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Prospective tReatment EffiCacy in IPF uSlng genOtype for Nac Selection (PRECISIONS) trial and Molecular Endophenotyping in Idiopathic Pulmonary Fibrosis and Interstitial Lung Diseases study

Award Number: U24HL145265

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer