Studies lung scarring that gets worse over time in adults with interstitial lung disease
Follows adults with interstitial lung disease for 24 months, collecting health data and samples.
Key facts
- Who runs it
- University of Massachusetts, Worcester
- Where
- Paris and Rennes, FranceSee the 2 sitesAlso in 12 other countries, 22 sites
- Trial code
- Registry title
- PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 1 May 2025
- Expected to end
- Dec 2029
- Type of study
- Observational
- Record updated
- 18 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 with fibrosing interstitial lung disease that is not idiopathic pulmonary fibrosis. They will be followed for 24 months.
- Age
- 18-80 years
- Sex
- All sexes
- Disease stage
- Fibrosing interstitial lung disease (ILD) that is not IPF, due to connective tissue disease ILD, fibrotic hypersensitivity pneumonitis, or non-IPF idiopathic interstitial pneumonia. Diagnosed no more than 5 years before the first visit.
- Earlier treatment
- People taking nintedanib or nerandomilast at Visit 1 cannot join. People who got an investigational drug in the 4 weeks before the enrollment visit (or 5 times the half-life, if longer) cannot join.
Main reasons for not taking part
- Very mild ILD affecting less than 5% of the lung on the scan
- Emphysema over 15% of total lung volume, or more than the fibrosis
- Active cancer within one year (except non-melanoma skin cancer treated locally)
- Cannot complete full lung function tests (spirometry and DLCO)
- Pregnant, or planning pregnancy during follow-up
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Taking nintedanib or nerandomilast at Visit 1
- Pregnancy at screening or plans to become pregnant during follow-up
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in France
Also in 12 other countries, 22 sites
- Bichat, APHPParis, FranceContact: Raphael Borie, MD, PhDNot yet recruiting
- CHU PontchaillouRennes, FranceContact: Stephane Jouneau, MDNot yet recruiting
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
- Plain-language title
- Studies lung scarring that gets worse over time in adults with interstitial lung diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06855329, who can take part
- Record updated
- 18 August 2026