Pulmonary Fibrosis Foundation Patient Registry
Condition: Interstitial Lung Disease (ILD); Idiopathic Pulmonary Fibrosis (IPF)
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Fibrosis
Study type: Observational [Patient Registry]

Summary: 
      The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000
      patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US.
      The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to
      have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of
      well-characterized patients with interstitial lung disease (ILD) for participation in
      retrospective and prospective research
    

Detailed description: 
      The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000
      patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US.
      The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to
      have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of
      well-characterized patients with interstitial lung disease (ILD) for participation in
      retrospective and prospective research.

      Patients who meet inclusion and exclusion criteria and are being treated at a Registry site
      can be asked to participate. Patients will be required to read and sign an Institutional
      review board(IRB)-approved informed consent document prior to any Registry activity taking
      place.

      At the time of informed consent, participants will be asked to indicate if they are
      interested in being contacted by Registry site personnel for potential participation in
      future clinical trials and/or studies. Participants who opt out will not be contacted for
      future studies.

      No clinical procedures, testing, or diagnostics will be required by virtue of Registry
      participation. Participants will permit Registry staff to abstract clinical data obtained as
      part of routine clinical care in the diagnosis and treatment of ILD. These data will be
      entered into a web-based, electronic data capture (EDC) by the Registry staff to at regular
      intervals. Some of these data will be retrospective, having been collected prior to
      consenting for the Registry.

      Computed tomography (CT) images collected for diagnosis and / or treatment will be
      de-identified at the Registry site and uploaded to a secure server that is a 21 Code of
      Federal Regulations (CFR) Part 11, Good Clinical Practice (GCP), and HIPAA compliant online
      imaging repository.

      Participants will be asked to complete patient reported outcome (PRO) surveys related to ILD
      symptoms and quality of life at the time of enrollment and during clinical follow-up
      visits.Participants who are not seen for clinical follow-up within 12 months will be
      contacted by telephone or mail by Registry site personnel to complete the PRO measures.

      The University of Michigan Statistical Analysis of Biomedical and Educational Research
      (SABER) unit will serve as the Registry Data Coordinating Center and will manage data entered
      into a web based, CFR 21 Part 11 compliant electronic data capture (EDC) system by the
      Registry sites.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        At least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical
        sites in the US. The Pulmonary Fibrosis Foundation Patient Registry will collect data on at
        least 2,000 patients at approximately 40 clinical sites in the US. The Registry is
        targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic
        pulmonary fibrosos (IPF).
      
Biospecimen description: 
      whole blood, plasma, PAXgene