PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Recruiting now

Conditions studied: Progressive Pulmonary Fibrosis, Interstitial Lung Disease

In brief

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.

Key facts

Study ID

NCT06855329

Run by

University of Massachusetts, Worcester

People needed

500

Starts

2025-05-01

Expected to finish

2029-12-01

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of Texas Southwestern — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Prince Charles Hospital — Brisbane, Queensland, Australia
• Austin Health — Melbourne, Victoria, Australia
• University of Calgary — Calgary, Alberta, Canada
• University of British Columbia — Vancouver, British Columbia, Canada
• University College Dublin — Dublin, Ireland, Ireland
• Royal Brompton — London, Greater London, United Kingdom
• University Hospital Southampton — Southampton, Hampshire, United Kingdom

Full record on ClinicalTrials.gov

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