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Summary

for people ages 18–99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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

Details

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.

Keywords

Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF) Fibrosis Lung Diseases Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial

Eligibility

You can join if…

Open to people ages 18–99

  1. 18 years old or older
  2. Understand and sign the informed consent document
  3. ILD Diagnosis must be made / confirmed at a participating Registry center.
  4. The diagnostic evaluation must include, at a minimum, a medical history, physical examination, pulmonary function testing and a computerized tomography (CT) scan of the chest.
  5. If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
  6. Anticipated additional follow up at the Registry center within one year.

You CAN'T join if...

  1. Diagnosed with:
  2. Sarcoid
  3. Lymphangioleiomyomatosis (LAM)
  4. Pulmonary alveolar proteinosis (PAP)
  5. Cystic fibrosis (CF)
  6. Amyloidosis

Locations

  • University of California at San Francisco accepting new patients
    San Francisco, California, 94143-2204, United States
  • Stanford University accepting new patients
    Stanford, California, 94305, United States
  • UCLA, David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles, California, 90095, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Michigan
ID
NCT02758808
Lead Scientist
Brett Ley
Study Type
Observational [Patient Registry]
Last Updated
November 3, 2017
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