Pulmonary Fibrosis Foundation Patient Registry

Completed

• Conditions: Interstitial Lung Disease (ILD); Idiopathic Pulmonary Fibrosis (IPF)

• Registration Number: NCT02758808
• Lead Sponsor: Pulmonary Fibrosis Foundation

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

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 Timeline

• Study Start: 2016-03-29
• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-03
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-05
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2004

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:

2. Sarcoid

3. Lymphangioleiomyomatosis (LAM)

4. Pulmonary alveolar proteinosis (PAP)

5. Cystic fibrosis (CF)

6. Amyloidosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in % predicted FVC	Up to 55 months	Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Change in % predicted DLCO	Up to 55 months	Analysis of registry data will lead to aggregated reports summarizing the pulmonary function

Trial Locations

Locations (42)

University fo Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Dignity Health St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

The University of Arizona; 🇺🇸 Tucson, Arizona, United States

UCLA, David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Piedmont Healthcare; 🇺🇸 Austell, Georgia, United States

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