Pulmonary Fibrosis Foundation Community Registry

Pulmonary fibrosis (PF) results from a diverse group of health conditions and affects the lives of patients (including those who are post lung transplant), caregivers and family members. The Pulmonary Fibrosis Foundation Community Registry will offer an online portal where participants can self-enroll and directly contribute information about their experience with PF to be compiled into a longitudinal data set for use by researchers.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Interstitial Lung Disease; Lung Fibrosis

Detailed Description

The PFF Community Registry is an observational, longitudinal cohort study. The Community Registry will enroll three different cohort groups:

1. Patients with PF, including those who are post lung transplant
2. Caregivers of patients with PF
3. Family members of patients with PF

This is an online registry open to individuals affected by PF in the US. It is not associated with a physical location or institution. Individuals may self-enroll online and contribute data to the Community Registry by answering a series of surveys at regular intervals.

Participants may also elect to be contacted about future research projects through the PFF Community Registry portal. However, this is not required to participate in the Community Registry itself.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Joseph Colbert, BA; Phone Number: 734-615-9813; Email: pffr-dcc-pm@umich.edu
• Study Contact Backup: Name: Jessica E Shore, PhD; Phone Number: 312-818-5731; Email: registry@pulmonaryfibrosis.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Pulmonary Fibrosis Foundation
      • Principal Investigator: Kevin Flaherty, MD
      • Contact: Kevin Flaherty, MD; Phone Number: 844-825-5733; Email: registry@pulmonaryfibrosis.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The Community Registry will enroll three different cohort groups:

1. Patients with PF or ILD, including those who are post lung transplant
2. Caregivers of patients with PF or ILD
3. Family members of patients with PF or ILD

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form online
2. Male or female, aged 18 or older

3. Affected by PF as a member of at least one of the following cohorts:

   1. An individual diagnosed with PF or ILD, including those who are post lung transplant, or
   2. An individual who has cared (currently or in the past) for an individual with PF or ILD, and / or
   3. A family member (defined as parent, full or half-sibling, or child) of an individual with PF or ILD.
4. Has internet access and a valid email address.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Primary residence or place of care is outside of the US.
2. Inability or unwillingness of a participant to provide informed consent or comply with study protocol.
3. Any condition or circumstance not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

4. Patients who were diagnosed with any of the below lung diseases. Similarly caregivers and family members associated with these diseases would be excluded.

   • Sarcoid
   • Lymphangioleiomyomatosis (LAM)
   • Pulmonary alveolar proteinosis (PAP)
   • Cystic fibrosis (CF)
   • Amyloidosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Patients; An individual diagnosed with PF or ILD, including those who are post lung transplant.
Family Members; A family member (defined as biological parent, full or half-sibling, or biological child) of an individual with PF or ILD.
Caregivers; An individual who has cared (currently or in the past) for an individual with PF or ILD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who have or had interstitial lung disease (ILD) enrolled in the PFF Community Registry	3 years
Number of caregivers of patients who have or had ILD enrolled in the PFF Community Registry	3 years
Number of family members of patients who have or had ILD enrolled in the PFF Community Registry	3 years

Collaborators and Investigators

• Sponsor: Pulmonary Fibrosis Foundation
• Collaborators: University of Michigan
• Investigators: Study Chair: Kevin R Flaherty, MD, Pulmonary Fibrosis Foundation

Publications and helpful links

Helpful Links

• Pulmonary Fibrosis Foundation Registry Information

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: HUM00202724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No