PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Massachusetts, Worcester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
Patients with non-idiopathic pulmonary fibrosis (non-IPF) fibrosing ILD, including connective tissue disease associated ILD (CTD-ILD), fibrotic hypersensitivity pneumonitis (fHP) and non-IPF idiopathic interstitial pneumonia (IIP).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Transplant-free survival (TFS)
TFS is defined as the time from the 12-month pulmonary function tests to death or lung transplant. Censoring will occur at 12-months or earlier if lost to follow-up.
Time frame
12-months to 24-months (following an observation period from 0 months to 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
University of Michigan
Collaborator
University of Virginia
Collaborator
Johannes Gutenberg University Mainz
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Source ClinicalTrials.gov