Progressive Pulmonary FibrosisPRIME-PPFNCT06855329
PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
An observational study of Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by University of Massachusetts, Worcester at 24 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Progressive Pulmonary Fibrosis, Interstitial Lung Disease
- How many people
- 500 participants
- Where
- 24 sitesin 13 countries
- Study dates
- 1 May 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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).
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
24 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 13 countries
United States7 sites, 7 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Janelle Pugashetti, MD, vupugash@med.umich.edu
Nisha Mohan, vupugash@med.umich.edu
- Not yet recruiting
University of Colorado | Anschutz Medical Campus
Aurora, Colorado, 80045
Joyce Lee, MD, 303-724-6109, joyce.lee@cuanschutz.edu
Olivia Brohl, 303-724-0640, olivia.brohl@cuanschutz.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Tessy Paul, MD, 434-243-2398, TKP4N@hscmail.mcc.virginia.edu
Yousef Althulth, kpq5sk@uvahealth.org
- Recruiting
University of Texas Southwestern
Dallas, Texas, 75390
Chad Newton, MD, 214-645-6493, Chad.Newton@UTSouthwestern.edu
Nighat Sultana, MBBS, 214-645-6605, nighat.sultana@utsouthwestern.edu
- Not yet recruiting
Weill Cornell Medicine
New York, New York, 10065
Anna Podolanczuk, MD, MS, 646-962-2333, ajp9012@med.cornell.edu
Alicia Morris, MS, 646-962-2741, ajm2017@med.cornell.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Ganesh Raghu, MD, (206) 598-4967, graghu@uw.edu
Katherine Palaeologus, (206)843-0228, kpal444@uw.edu
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Roberto Caricchio, MD, lupus.caricchio@umassmed.edu
Betsy Peters, BSN, 774-455-4432, elizabeth.peters2@umassmed.edu
Australia3 sites, 3 recruiting
- Not yet recruiting
Prince Charles Hospital
Brisbane, Queensland, 4032
John Mackintosh, MD, +617 3139 4000, john.mackintosh@health.qld.gov.au
Brittany Cooper, +617 3139 7222, Brittany.cooper2@health.qld.gov.au
- Not yet recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Tamera Corte, MBBS, PhD, +61 (0)2 9515 6120, Tamera.Corte@health.nsw.gov.au
Jessica Rhodes, +61 (0) 2 9515 5006, slhd-rpa-ildclinicaltrials@health.nsw.gov.au
- Not yet recruiting
Austin Health
Melbourne, Victoria, 3000
Yet Khor, MD, +613 9596 5000, yet.khor@monash.edu
Lisa Fuhmeister, +613 9596 3874, Lisa.FUHRMEISTER@austin.org.au
Germany3 sites, 3 recruiting
- Not yet recruiting
Prüfzentrum der GWT am Lungenzentrum Coswig
Coswig, Saxony, 01445
Dirk Koschel, MD, 0352365202, koschel@lungenzentrum-coswig.de
Nicole Schneider, 0352365452, schneider_n@lungenzentrum-coswig.de
- Recruiting
University Medical Center Mainz
Mainz, 55131
Michael Kreuter, MD, + 49 6131 17-7271, kreuterm@uni-mainz.de
Marion Wencker, MD, +49 6131 17-5778, marion.wencker@unimedizon-mainz.de
- Not yet recruiting
LMU Munich
Munich, 81377
Juergen Behr, MD, +4989440075310, juergen.behr@med.uni-muenchen.de
Tobias Veit, +4989440073071, tobias.veit@med.uni-muenchen.de
France2 sites, 2 recruiting
- Not yet recruiting
Bichat, APHP
Paris, 75018
Raphael Borie, MD, PhD, +33140256800, raphael.borie@aphp.fr
Bruno Crestani, +33140258237, bruno.crestani@aphp.fr
- Not yet recruiting
Chu Pontchaillou
Rennes, 35000
Stephane Jouneau, MD, 02-99-82-24-78, stephane.jouneau@chu-rennes.fr
Melanie Rault, 02-99-28-97-95, melanie.rault@chu-rennes.fr
Austria1 site, 1 recruiting
- Not yet recruiting
Medical University of Graz
Graz, 8036
Nikolaus Kneidinger, MD, +43 316 385 12183, nikolaus.kneidinger@medunigraz.at
Laura Helleis, +43 316 385 12974, laura.helleis@medunigraz.at
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
Chris Ryerson, MD, 1(604)258-8682, Chris.Ryerson@hli.ubc.ca
Miriam Margari, 1(236)808-0804, miriam.margari@hli.ubc.ca
Czechia1 site, 1 recruiting
- Not yet recruiting
Charles University and Faculty Thomayer Hospital
Prague, 140 59
Martina Koziar Vašáková, MD, PhD, +420 261 082 372, martina.koziarvasakova@ftn.cz
Martin Sekal, +420 261 083 853, martin.sekal@ftn.cz
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus, 8200
Janne Møller, MD, PhD, +45 78462201 / +45 61770550
Elisabeth Bendstrup, PhD, +45 78462201, karbends@rm.dk
Hungary1 site, 1 recruiting
- Not yet recruiting
Semmelweis University
Budapest, 1083
Veronika Muller, MD, PhD, DSc, +36208259181, muller.veronika@semmelweis.hu
Secretarial office of Department of Pulmonology, +3613559733/57041, titkarsag.pulm@semmelweis.hu
Ireland1 site, 1 recruiting
- Recruiting
University College Dublin
Dublin, Ireland, D04 T6F4
Cormac McCarthy, MD, PhD, +35312213323, cormac.mccarthy@ucd.ie
Gillian Buckley, +353012214000, Gillianbuckley@svhg.ie
Italy1 site, 1 recruiting
- Not yet recruiting
Rimini and Riccione Hospitals, AUSL Romagna
Rimini, 47923
Sara Tomassetti, MD, +39 347 8247783, s.tomassetti@gmail.com
Aurora Mazzeo, +39 0541705866, aurora.mazzeo@irst.emr.it
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
M S Wijsenbeek, MD, 0107030323, research.longziekten@erasmusmc.nl
Maaike Hoedemakers, 0107040949, m.hoedemakers@erasmusmc.nl
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Claudia Valenzuela, MD, +34 915202277, claudiavale@hotmail.com
Elisa Martinez Besteiro, MD, +34 915202277
About this study
Official title: PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
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.
Read the detailed description
This is a prospective, cohort study with no study investigational therapy prescribed. 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) will be recruited. Consented participants with non-IPF ILD will be carefully phenotyped with extensive clinical, physiological, and imaging data. After confirmation of eligibility, participants will undergo protocolized follow-up over 24 months. Clinical data and blood biospecimens will be collected at protocolized time points throughout the study.
The primary outcome is 12-month transplant-free survival (TFS), following a 12-month observation period with TFS defined as the time from 12-month PFT to death, lung transplant or censoring at 12 months or earlier if lost to follow-up. This research will determine whether a ≥10% relative decline in FVC occurring during the 12-month observation period is associated with TFS over the subsequent 12 months. The investigators will then explore other proposed PPF criteria using the same approach. Additionally, the investigators will determine test performance characteristics of a novel proteomic biomarker for predicting PPF at 12 months and compare performance of this classifier to a multi-dimensional approach that incorporates clinical data and quantitative CT data.
- Keywords
- Progressive pulmonary fibrosis, Interstitial lung disease, PRIME, PRIME-PPF, PPF
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months to 24-months (following an observation period from 0 months to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 May 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, University of Virginia, Johannes Gutenberg University Mainz, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Fernando J Martinez, University of Massachusetts, Worcester
- Investigators
- Fernando J Martinez, MD, MS, Principal investigator, University of Massachusetts, WorcesterJustin Oldham, MD, MS, Principal investigator, University of MichiganCathie Spino, DSc, Principal investigator, University of MichiganImre Noth, MD, MS, Principal investigator, University of VirginiaMichael Kreuter, MD, Principal investigator, Johannes Gutenberg University MainzDinesh Khanna, MD, MS, Principal investigator, University of MichiganLuca Richeldi, MD, PhD, Principal investigator, Policlinico Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855329
- Sponsor's protocol ID
- STUDY00002006
- Acronym
- PRIME-PPF
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT06855329
- Acronym / sponsor ID
- PRIME-PPF / STUDY00002006
- Keywords
- Progressive pulmonary fibrosis, Interstitial lung disease, PRIME, PRIME-PPF, PPF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Michigan, University of Virginia, Johannes Gutenberg University Mainz, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, cohort study with no study investigational therapy prescribed. 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) will be recruited. Consented participants with non-IPF ILD will be carefully phenotyped with extensive clinical, physiological, and imaging data. After confirmation of eligibility, participants will undergo protocolized follow-up over 24 months. Clinical data and blood biospecimens will be collected at protocolized time points throughout the study.
The primary outcome is 12-month transplant-free survival (TFS), following a 12-month observation period with TFS defined as the time from 12-month PFT to death, lung transplant or censoring at 12 months or earlier if lost to follow-up. This research will determine whether a ≥10% relative decline in FVC occurring during the 12-month observation period is associated with TFS over the subsequent 12 months. The investigators will then explore other proposed PPF criteria using the same approach. Additionally, the investigators will determine test performance characteristics of a novel proteomic biomarker for predicting PPF at 12 months and compare performance of this classifier to a multi-dimensional approach that incorporates clinical data and quantitative CT data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transplant-free survival (TFS)
Time frame: 12-months to 24-months (following an observation period from 0 months to 12 months)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Progressive Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
Progressive Pulmonary Fibrosis, Interstitial Lung Disease
Not yet recruitingPhase 3
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando J Martinez, MD, MS principal investigator
University of Massachusetts, Worcester
Justin Oldham, MD, MS principal investigator
University of Michigan
Cathie Spino, DSc principal investigator
University of Michigan
24 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Pulmonary Fibrosis and Interstitial Lung Disease, run by University of Massachusetts, Worcester at 24 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Germany, France, Austria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando J Martinez, MD, MS (508-334-8685, fernando.martinez1@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival (TFS) (time frame: 12-months to 24-months (following an observation period from 0 months to 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.