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

> **NIH NIH U24** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $627,206

## Abstract

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.

## Key facts

- **NIH application ID:** 10828307
- **Project number:** 5U24HL145265-05
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** KEVIN R FLAHERTY
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $627,206
- **Award type:** 5
- **Project period:** 2019-09-20 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10828307

## Citation

> US National Institutes of Health, RePORTER application 10828307, Prospective tReatment EffiCacy in IPF uSlng genOtype for Nac Selection (PRECISIONS) trial and Molecular Endophenotyping in Idiopathic Pulmonary Fibrosis and Interstitial Lung Diseases study (5U24HL145265-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10828307. Licensed CC0.

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