NCT06855329 PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis
| NCT ID | NCT06855329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Progressive Pulmonary Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-05-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Fernando J Martinez, MD, MS
PRINCIPAL INVESTIGATOR
University of Massachusetts, Worcester
Frequently Asked Questions
Who can join the NCT06855329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Progressive Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855329 currently recruiting?
Yes, NCT06855329 is actively recruiting participants. Contact the research team at fernando.martinez1@umassmed.edu for enrollment information.
Where is the NCT06855329 trial being conducted?
This trial is being conducted at Worcester, United States, Ann Arbor, United States, Dallas, United States, Charlottesville, United States and 9 additional locations.
Who is sponsoring the NCT06855329 clinical trial?
NCT06855329 is sponsored by University of Massachusetts, Worcester. The principal investigator is Fernando J Martinez, MD, MS at University of Massachusetts, Worcester. The trial plans to enroll 500 participants.