NCT06855329Recruiting
PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 1 May 2025
- Primary completion date
- Dec 2029
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06855329
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 May 2025 to the primary completion date, Dec 2029
- 24 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Taking nintedanib or nerandomilast at Visit 1.
- Pregnancy at screening or plans to become pregnant during follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Prince Charles Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Not yet recruiting |
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Not yet recruiting |
| Austin Health Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Charles University and Faculty Thomayer Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Prüfzentrum der GWT am Lungenzentrum Coswig Coordinator of this site? Confirm its status | Coswig | Germany | Not yet recruiting |
| University Medical Center Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| LMU Munich Coordinator of this site? Confirm its status | Munich | Germany | Not yet recruiting |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Not yet recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Bichat, APHP Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| CHU Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Not yet recruiting |
| University College Dublin Coordinator of this site? Confirm its status | Dublin | Ireland | Recruiting |
| Rimini and Riccione Hospitals, AUSL Romagna Coordinator of this site? Confirm its status | Rimini | Italy | Not yet recruiting |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Not yet recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Texas, Southwestern Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| University of Massachusetts Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.