RECRUITING

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

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Conditions

Progressive Pulmonary FibrosisInterstitial Lung DiseasePRIMEPRIME-PPFPPF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PRIME-PPF: PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Quick Facts

Study Start:2025-05-01
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06855329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Diagnosis of Fibrotic ILD as determined by site investigator.
  3. * Willingness to comply with study procedures and follow-up.
  4. * Provide written informed consent.
  1. * Site diagnosis of fibrosing ILD \>5 years prior to Visit 1 (Screening and Baseline Visit).
  2. * 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.
  3. * 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.
  4. * Active malignancy within one year prior to Visit 1 (except for non-melanoma skin cancer requiring local treatment).
  5. * 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.
  6. * Taking nintedanib or nerandomilast at Visit 1.
  7. * Pregnancy at screening or plans to become pregnant during follow-up.
  8. * 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.

Contacts and Locations

Study Contact

Fernando J Martinez, MD, MS
CONTACT
508-334-8685
fernando.martinez1@umassmed.edu
Elizabeth Peters, BSN
CONTACT
774-455-4432
elizabeth.peters2@umassmed.edu

Principal Investigator

Fernando J Martinez, MD, MS
PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Justin Oldham, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan
Cathie Spino, DSc
PRINCIPAL_INVESTIGATOR
University of Michigan
Imre Noth, MD, MS
PRINCIPAL_INVESTIGATOR
University of Virginia
Michael Kreuter, MD
PRINCIPAL_INVESTIGATOR
Johannes Gutenberg University Mainz
Dinesh Khanna, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan
Luca Richeldi, MD, PhD
PRINCIPAL_INVESTIGATOR
Policlinico Gemelli

Study Locations (Sites)

University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Fernando J Martinez, MD, MS, PRINCIPAL_INVESTIGATOR, University of Massachusetts Chan Medical School
  • Justin Oldham, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Cathie Spino, DSc, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Imre Noth, MD, MS, PRINCIPAL_INVESTIGATOR, University of Virginia
  • Michael Kreuter, MD, PRINCIPAL_INVESTIGATOR, Johannes Gutenberg University Mainz
  • Dinesh Khanna, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Luca Richeldi, MD, PhD, PRINCIPAL_INVESTIGATOR, Policlinico Gemelli

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2029-12

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Progressive pulmonary fibrosis
  • Interstitial lung disease
  • PRIME
  • PRIME-PPF
  • PPF

Additional Relevant MeSH Terms

  • Progressive Pulmonary Fibrosis
  • Interstitial Lung Disease