PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Description

This is a prospective, observational cohort study. Participants with non-idiopatic pulmonary fibrosis, interstitial lung disease (ILD) will be followed for 24 months to systematically collect clinical, imaging, and biospecimen data. The primary objective is to optimize progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate a novel PPF classifier and assess performance durability over time, and 2) Determine whether multi-dimensional PPF prediction outperforms component approaches.

Conditions

Progressive Pulmonary Fibrosis, Interstitial Lung Disease

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Study Overview

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Study Details

Study overview

This is a prospective, observational cohort study. Participants with non-idiopatic pulmonary fibrosis, interstitial lung disease (ILD) will be followed for 24 months to systematically collect clinical, imaging, and biospecimen data. The primary objective is to optimize progressive pulmonary fibrosis (PPF) classification and establish PPF incidence for key ILD subtypes. Additional exploratory objectives are to 1) Prospectively validate a novel PPF classifier and assess performance durability over time, and 2) Determine whether multi-dimensional PPF prediction outperforms component approaches.

PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Condition
Progressive Pulmonary Fibrosis
Intervention / Treatment

-

Contacts and Locations

Worcester

University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States, 01655

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Dallas

University of Texas Southwestern, Dallas, Texas, United States, 75390

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-80 years with a diagnosis of non-IPF fibrosing ILD due to CTD-ILD, fHP, or non-IPF IIP based on central review
  • * Diagnosis of Fibrotic ILD as determined by site investigator.
  • * Willingness to comply with study procedures and follow-up.
  • * Provide written informed consent.
  • * Site diagnosis of fibrosing ILD \>5 years prior to Visit 1 (Screening and Baseline Visit).
  • * Minimal ILD, defined as reticular opacities and/or ground-glass opacities without architectural distortion (traction bronchiolectasis/bronchiectasis or honeycombing) affecting \< 5% of the lung on centralized evaluation of HRCT at Visit 1 (Screening and Baseline Visit). High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
  • * Extent of emphysema \>15% of total lung volume or greater than extent of fibrosis based on central, qualitative assessment of HRCT at Visit 1. High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
  • * Active malignancy within one year prior to Visit 1 (except for non-melanoma skin cancer requiring local treatment).
  • * Inability to complete full PFT (spirometry and DLCO) at Visit 1. Historical PFT may be used if performed within 90 days prior to Visit 1.
  • * Taking nintedanib or nerandomilast at Visit 1.
  • * Pregnancy at screening or plans to become pregnant during follow-up.
  • * Participation in an interventional clinical trial for fibrotic ILD at the time of Visit 1, or receipt of an investigational drug within the previous 4 weeks of the enrollment visit (Visit 1) or 5 times the half-life, if longer.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Massachusetts, Worcester,

Fernando J Martinez, MD, MS, PRINCIPAL_INVESTIGATOR, University of Massachusetts Chan Medical School

Justin Oldham, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Cathie Spino, DSc, PRINCIPAL_INVESTIGATOR, University of Michigan

Imre Noth, MD, MS, PRINCIPAL_INVESTIGATOR, University of Virginia

Michael Kreuter, MD, PRINCIPAL_INVESTIGATOR, Johannes Gutenberg University Mainz

Dinesh Khanna, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Luca Richeldi, MD, PhD, PRINCIPAL_INVESTIGATOR, Policlinico Gemelli

Study Record Dates

2029-12