# Clinical Core

> **NIH NIH P01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $636,177

## Abstract

PROJECT SUMMARY
The Clinical and Biospecimen Core (Core A) will support each Project in the Program by implementing all
proposed studies involving human research participants. The long-term goal of the Program is to identify new
strategies to prevent pulmonary fibrosis (PF) by advancing understand of the pathobiological cascade that
initiates progressive PF. The Program is focused on the pre-symptomatic period, which represents the ideal
time for therapeutic interventions to modify the course of PF. Using state-of-the-art single-cell and spatial
transcriptomic approaches, biomarker analysis, and environmental exposure assessment, the Projects will
elucidate critical factors that underlie early disease pathogenesis. Dr. Salisbury, Dr. Blackwell, and other Core
personnel have established a reputation as leaders in PF research, including conduct of investigator-initiated
clinical trials and observational studies. The Familial Pulmonary Fibrosis (FPF) Registry is an observational
study maintained by Core personnel that has been a key resource to identify asymptomatic members of FPF
families who are at risk to develop FPF. The At-Risk for FPF Cohort, the backbone of this Program, was
incepted in 2008 and directed by Dr. Salisbury since 2019. The At-Risk Cohort has already recruited 489
research volunteers, who are asymptomatic relatives of patients with FPF, to undergo serial screening for pre-
clinical PF with high-resolution chest CTs (HRCTs), pulmonary function tests, and blood donation. The Specific
Aims for Core A are to: 1) Recruit research participants and perform all clinical procedures; 2) Coordinate
clinical studies, collect, maintain, and distribute data collected from human research subjects, and maintain
regulatory requirements; and 3) Process, catalog, and distribute biological specimens collected from human
research subjects. Key At-Risk Cohort sub-studies implemented by the Core include the Lung Sampling
(Bronchoscopy) in Pre-Clinical FPF Sub-Study, in which a total of 40 additional At-Risk Cohort participants will
undergo lung sampling via a research bronchoscopy with bronchoalveolar lavage (BAL), bronchial brushing
(for airway epithelial cell collection), and transbronchial lung biopsies, and the Exposures in Pre-Clinical FPF
Sub-Study, in which up to 300 At-Risk Cohort participants will undergo a detailed environmental exposure
assessment with prospective sampling to measure potentially harmful exposures. Core A supports the
Program’s goals by maintaining the At-Risk for FPF Cohort, identifying those with pre-clinical (pre-
symptomatic) PF, implementing key sub-studies, and providing each Project with the necessary samples and
data.

## Key facts

- **NIH application ID:** 10846184
- **Project number:** 1P01HL172729-01
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Margaret Louise Salisbury
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $636,177
- **Award type:** 1
- **Project period:** 2024-09-17 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10846184

## Citation

> US National Institutes of Health, RePORTER application 10846184, Clinical Core (1P01HL172729-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10846184. Licensed CC0.

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