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PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Recruitingn/aAges 18 Years - 80 YearsAllUniversity of Massachusetts, Worcester
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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. Exclusion Criteria: * 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.
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What it tests

  • Not listed
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Where

24 sites
University of Colorado | Anschutz Medical Campus
Aurora, United States
University of Massachusetts Chan Medical School
Worcester, United States
University of Michigan
Ann Arbor, United States
Weill Cornell Medicine
New York, United States
University of Texas Southwestern
Dallas, United States
University of Virginia
Charlottesville, United States
University of Washington
Seattle, United States
Royal Prince Alfred Hospital
Camperdown, Australia

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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