# Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2022 · $1,153,760

## Abstract

PROJECT ABSTRACT
The purpose of this proposal is to develop clinical prediction tools to risk stratify patients with
pulmonary sarcoidosis. Because the course of sarcoidal inflammation lasts for many years even
in those with self-limiting sarcoid, the lack of prognostic indicators upon which to develop a
management plan is not a trivial issue for both patient and physician. Thus, without
prognostication tools, clinicians will not be able to improve the longitudinal care they provide for
the types of outcomes that are used in the clinic. The conception of this study was motivated by
the preliminary data showing that levels of blood protein and RNA transcripts related to interferon
inflammation were predictive of future declines in lung function using Cox proportional hazards
modeling. An important feature of the study design is the focus on clinically relevant outcomes
and clinical variables so that results can be immediately translated into clinical practice. This goal
is realized in Aim 1 in which we will deliver the best performing clinical prediction model that relies
only on clinically available data and lab tests to predict a clinical outcome used in pulmonary
clinics to define sarcoidosis disease progression. This outcome is a clinically meaningful decline
in lung function. In Aim 2, we will measure the added value of incorporating novel blood-based
interferon related markers into the clinical prediction models. The goal of this Aim is to identify
which novel markers should be developed and moved into the clinical arena for use in sarcoidosis
prognostication. Finally, in Aim 3 we will apply these models to an important clinical management
problem in sarcoidosis which is identifying the optimal monitoring frequency for a given patient.
Addressing this last question is the first step towards being able to better anticipate disease
progression before extensive organ damage occurs. The team of sarcoidosis investigators are
highly qualified to execute this study because they have a track record of performing sarcoidosis
clinical research, have ongoing collaborations and have participated in prior studies that involve
biospecimen collection from patients including NIH-sponsored consortium studies. To execute
this study, the investigators will contribute longitudinal biospecimens and clinical data from 357
patients with sarcoidosis that have been enrolled in longitudinal cohorts at centers across the US.
Two hundred additional patients will be enrolled and followed for up to 39 months leading to a
total sample size of 557, of which a majority will be African American. Our team also includes a
uniquely qualified biostatistician, Dr. Charles McCulloch, who has pioneered aspects of the
longitudinal modeling approach we will be using. Therefore, the proposed Aims have a high
likelihood of success for tackling this long-overdue clinical problem.

## Key facts

- **NIH application ID:** 10446452
- **Project number:** 1R01HL157533-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** LAURA L KOTH
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,153,760
- **Award type:** 1
- **Project period:** 2022-04-01 → 2026-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10446452

## Citation

> US National Institutes of Health, RePORTER application 10446452, Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis (1R01HL157533-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10446452. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
