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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
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

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Graz
Coordinator of this site? Confirm its status
GrazAustriaNot yet recruiting
Prince Charles Hospital
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BrisbaneAustraliaNot yet recruiting
Royal Prince Alfred Hospital
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CamperdownAustraliaNot yet recruiting
Austin Health
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MelbourneAustraliaNot yet recruiting
University of British Columbia
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VancouverCanadaRecruiting
Charles University and Faculty Thomayer Hospital
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PragueCzechiaNot yet recruiting
Prüfzentrum der GWT am Lungenzentrum Coswig
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CoswigGermanyNot yet recruiting
University Medical Center Mainz
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MainzGermanyRecruiting
LMU Munich
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MunichGermanyNot yet recruiting
Aarhus University Hospital
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AarhusDenmarkNot yet recruiting
Hospital Universitario de la Princesa
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MadridSpainNot yet recruiting
Bichat, APHP
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ParisFranceNot yet recruiting
CHU Pontchaillou
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RennesFranceNot yet recruiting
Semmelweis University
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BudapestHungaryNot yet recruiting
University College Dublin
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DublinIrelandRecruiting
Rimini and Riccione Hospitals, AUSL Romagna
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RiminiItalyNot yet recruiting
Erasmus MC
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RotterdamNetherlandsRecruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
University of Colorado Anschutz Medical Campus
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AuroraUnited StatesNot yet recruiting
University of Virginia
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CharlottesvilleUnited StatesRecruiting
University of Texas, Southwestern
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DallasUnited StatesRecruiting
Weill Cornell Medicine
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New YorkUnited StatesNot yet recruiting
University of Washington
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SeattleUnited StatesRecruiting
University of Massachusetts Chan Medical School
Coordinator of this site? Confirm its status
WorcesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.