Actively Recruiting

Age: 18Years - 85Years
All Genders
ID06702228

Precision Diagnosis and Care for Families With Pulmonary Fibrosis in Ireland PRECISE-PF

Led by Royal College of Surgeons, Ireland · Updated on 2024-11-22

300

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

Sponsors

R

Royal College of Surgeons, Ireland

Lead Sponsor

P

patientMpower Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying pulmonary fibrosis, a group of lung diseases that cause lung scarring and breathing difficulties. This study focuses on how genes and environmental factors contribute to pulmonary fibrosis development and progression, especially in people with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), and connective tissue disease-related interstitial lung disease (CTD-ILD). The goal is to better understand disease behavior and improve early identification of progressive cases. Participants are grouped into three categories: those with familial pulmonary fibrosis, those with IPF without family history, and those with CTD-ILD. The study follows 300 patients for one year, monitoring lung function and disease progression using several tests, including spirometry, six-minute walk tests, high-resolution CT scans analyzed by AI, genetic testing, and quality of life questionnaires. Participants also use a home monitoring app to track lung function twice a week. During the study, patients undergo assessments at baseline, six months, and twelve months, including lung function tests, blood tests, exercise capacity evaluations, and questionnaire surveys. Researchers will analyze genetic variants, disease progression, and radiological patterns. The study aims to identify early signs of worsening disease and improve personalized diagnosis and care. Safety and overall health are monitored throughout the one-year follow-up.

CONDITIONS

Brief Title

Precision Diagnosis and Care for Families With Pulmonary Fibrosis in Ireland

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to give written informed consent.
  • Have a multidisciplinary team (MDT) diagnosis of fibrotic interstitial lung disease.
  • Belong to one of the following groups: have at least one relative with fibrotic ILD, have idiopathic pulmonary fibrosis (IPF) without family history, or meet criteria for rheumatoid arthritis, scleroderma, Sjogren's syndrome, idiopathic inflammatory myopathy, or systemic lupus erythematosus.
Not Eligible

You will not qualify if you...

  • Currently participating in an interventional clinical trial.
  • Change in clinical phenotype from initial radiological diagnosis to screening.
  • Diagnosis of acute or chronic hypersensitivity pneumonitis.
  • Diagnosis of asbestosis.
  • Life expectancy less than 12 months for any disease, including ILD.
  • Major extrapulmonary physiological restriction such as chest wall abnormality or large pleural effusion.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline to 1 year

Participants undergo diagnostic assessments including genetic testing, serology, spirometry, six minute walk test, and CT thorax scans.

Visits at 0, 6, and 12 months

Long-term Monitoring

Duration - Up to 12 months

Participants are monitored using home-based digital spirometry and pulse-oximetry via the PatientMPower Home Monitoring App with real-time feedback.

Twice weekly at-home monitoring

Trial Site Locations

Total: 1 location

1

Beaumont Hospital

Dublin, Ireland, D09V2N0

Actively Recruiting

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Research Team

K

Killian Hurley

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Frequently Asked Questions

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