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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 : September 26, 2019
Sponsor:
Collaborator:
Pulmonary Fibrosis Foundation
Information provided by (Responsible Party):
Cathie Spino, ScD, University of Michigan

Tracking Information
First Submitted Date April 14, 2016
First Posted Date May 3, 2016
Last Update Posted Date September 26, 2019
Study Start Date March 2016
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2019)
Proportion of subjects with various ILD diagnoses [ 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.
Original Primary Outcome Measures
 (submitted: April 27, 2016)
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.
Change History Complete list of historical versions of study NCT02758808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 24, 2019)
  • Proportion of subjects with various treatments over time [ 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.
  • ILD disease status, including pulmonary function and walk test results [ 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.
  • Health-related quality of life [ 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.
  • Survival [ 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Fibrosis Foundation Patient Registry
Official Title Pulmonary Fibrosis Foundation Patient Registry
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
whole blood, plasma, PAXgene
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).
Condition
  • Interstitial Lung Disease (ILD)
  • Idiopathic Pulmonary Fibrosis (IPF)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 27, 2016)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Muhammad Ishtiaq, PhD 7346153196 mishtiaq@umich.edu
Contact: Catherine A Spino, ScD 7346155469 spino@umich.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02758808
Other Study ID Numbers PFF01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cathie Spino, ScD, University of Michigan
Study Sponsor University of Michigan
Collaborators Pulmonary Fibrosis Foundation
Investigators
Study Chair: Kevin R Flaherty, MD University of Michigan
PRS Account University of Michigan
Verification Date September 2019