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Pulmonary Fibrosis Foundation Patient Registry (PFFR)

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ClinicalTrials.gov Identifier: NCT02758808
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Pulmonary Fibrosis Foundation
Information provided by (Responsible Party):
Cathie Spino, ScD, University of Michigan

Brief 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

Condition or disease
Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF)

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Pulmonary Fibrosis Foundation Patient Registry
Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021





Primary Outcome Measures :
  1. Aggregated reports summarizing the epidemiology of ILD, as well as disease, treatment and outcomes. [ Time Frame: 5 years ]
    Analysis of registry data will lead to aggregated reports summarizing the epidemiology of ILD, as well as disease, treatment and outcomes.


Biospecimen Retention:   Samples With DNA
whole blood, plasma, PAXgene


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  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.

    1. 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.
    2. If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
  4. Anticipated additional follow up at the Registry center within one year.

Exclusion Criteria:

  1. Diagnosed with:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758808


Contacts
Contact: Muhammad Ishtiaq, PhD 7346153196 mishtiaq@umich.edu
Contact: Catherine A Spino, ScD 7346155469 spino@umich.edu

  Show 42 Study Locations
Sponsors and Collaborators
University of Michigan
Pulmonary Fibrosis Foundation
Investigators
Study Chair: Kevin R Flaherty, MD University of Michigan

Responsible Party: Cathie Spino, ScD, Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02758808     History of Changes
Other Study ID Numbers: PFF01
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases