Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06855329

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Led by University of Massachusetts, Worcester · Updated on 2025-09-22

500

Participants Needed

13

Research Sites

239 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

U

University of Michigan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Fibrosing ILD diagnosed more than 5 years before screening and baseline visit
  • Minimal ILD affecting less than 5% of the lung without architectural distortion on HRCT
  • Emphysema covering more than 15% of total lung volume or greater than fibrosis extent on HRCT
  • Active malignancy within one year before screening except non-melanoma skin cancer requiring local treatment
  • Inability to complete full pulmonary function tests at screening
  • Taking nintedanib or nerandomilast at screening
  • Pregnancy at screening or plans to become pregnant during follow-up
  • Participation in an interventional fibrotic ILD clinical trial or investigational drug use within 4 weeks or 5 times the drug half-life before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

3

University of Texas Southwestern

Dallas, Texas, United States, 75390

Not Yet Recruiting

4

University of Virginia

Charlottesville, Virginia, United States, 22908

Not Yet Recruiting

5

University of Washington

Seattle, Washington, United States, 98195

Not Yet Recruiting

6

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Not Yet Recruiting

7

Prince Charles Hospital

Brisbane, Queensland, Australia, 4032

Not Yet Recruiting

8

Austin Health

Melbourne, Victoria, Australia, 3000

Not Yet Recruiting

9

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6

Not Yet Recruiting

10

University of British Columbia

Vancouver, British Columbia, Canada, V6Z 1Y6

Not Yet Recruiting

11

University College Dublin

Dublin, Ireland, Ireland, D04 T6F4

Not Yet Recruiting

12

Royal Brompton

London, Greater London, United Kingdom, SW3 6NP

Not Yet Recruiting

13

University Hospital Southampton

Southampton, Hampshire, United Kingdom, SO16 7DL

Not Yet Recruiting

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Research Team

F

Fernando J Martinez, MD, MS

CONTACT

E

Elizabeth Peters, BSN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis | DecenTrialz