Observational study on progressive pulmonary fibrosis and its classification

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study follows participants with non-idiopathic pulmonary fibrosis and interstitial lung disease over 24 months to collect clinical, imaging, and biospecimen data. The primary goal is to optimize the classification of progressive pulmonary fibrosis (PPF) and establish its incidence among key subtypes of interstitial lung disease. Participants will undergo systematic phenotyping and will have their clinical data and blood biospecimens collected at designated time points. The study will also validate a novel PPF classifier and compare its performance to multi-dimensional prediction approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Massachusetts Chan Medical School
  Worcester, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting
• University of Virginia
  Charlottesville, Virginia, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Fernando J Martinez, MD, MS — University of Massachusetts, Worcester
• Study coordinator: Fernando J Martinez, MD, MS
• Email: fernando.martinez1@umassmed.edu
• Phone: 508-334-8685

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.