PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
NCT ID: NCT06855329
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2025-05-01
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Fibrotic ILD as determined by site investigator.
* Willingness to comply with study procedures and follow-up.
* Provide written informed consent.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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University of Michigan
OTHER
University of Virginia
OTHER
Johannes Gutenberg University Mainz
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
University of Massachusetts, Worcester
OTHER
Responsible Party
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Fernando J Martinez
Professor
Principal Investigators
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Fernando J Martinez, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Justin Oldham, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Cathie Spino, DSc
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Imre Noth, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Michael Kreuter, MD
Role: PRINCIPAL_INVESTIGATOR
Johannes Gutenberg University Mainz
Dinesh Khanna, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Luca Richeldi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Policlinico Gemelli
Locations
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University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Prince Charles Hospital
Brisbane, Queensland, Australia
Austin Health
Melbourne, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
University College Dublin
Dublin, Ireland, Ireland
Royal Brompton
London, Greater London, United Kingdom
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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STUDY00002006
Identifier Type: -
Identifier Source: org_study_id
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