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Clinical Trials in Ireland / NCT06855329
Recruiting Observational

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

NCT06855329 · tracked via the Priya Life Science Ireland tracker
Sponsor
University of Massachusetts, Worcester
Phase
Observational
Started
2025-05-01
Last updated
2026-08-18

Condition(s) studied

Progressive Pulmonary FibrosisInterstitial Lung Disease

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
University of Colorado | Anschutz Medical Campus Aurora Colorado Not Yet Recruiting
University of Massachusetts Chan Medical School Worcester Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Weill Cornell Medicine New York New York Not Yet Recruiting
University of Texas Southwestern Dallas Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
University of Washington Seattle Washington Recruiting
Royal Prince Alfred Hospital Camperdown New South Wales Not Yet Recruiting
Prince Charles Hospital Brisbane Queensland Not Yet Recruiting
Austin Health Melbourne Victoria Not Yet Recruiting
Medical University of Graz Graz Austria Not Yet Recruiting
University of British Columbia Vancouver British Columbia Recruiting
Charles University and Faculty Thomayer Hospital Prague Czechia Not Yet Recruiting
Aarhus University Hospital Aarhus Denmark Not Yet Recruiting
Bichat, APHP Paris France Not Yet Recruiting
Chu Pontchaillou Rennes France Not Yet Recruiting
Prüfzentrum der GWT am Lungenzentrum Coswig Coswig Saxony Not Yet Recruiting
University Medical Center Mainz Mainz Germany Recruiting
LMU Munich Munich Germany Not Yet Recruiting
Semmelweis University Budapest Hungary Not Yet Recruiting
University College Dublin Dublin Ireland Recruiting
Rimini and Riccione Hospitals, AUSL Romagna Rimini Italy Not Yet Recruiting
Erasmus MC Rotterdam South Holland Recruiting
Hospital Universitario de La Princesa Madrid Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855329 on ClinicalTrials.gov ↗ ← All trials in Ireland