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Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
Study Purpose
This registry will collect data on the strategies used to achieve a diagnosis of Idiopathic
Pulmonary Fibrosis (IPF) and Chronic Fibrosing Interstitial Lung Disease with Progressive
Phenotype (ILD) and the treatment and management efforts applied throughout study follow-up,
clinical outcome events and patient reported outcome data. Blood samples will be collected
periodically throughout the study for use in future research efforts. For participants with
non-IPF, chronic fibrosing ILD with progressive phenotype, HRCT images will be collected
throughout the study for use in future research efforts.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Observational [Patient Registry]
Eligible Ages
30 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Willing and able to provide informed consent.
- Established a new diagnosis of IPF by the enrolling subspecialty center (as defined by
ATS/ERS/JRS/ALAT criteria)
- Age 30 years or older, or.
- Diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic
Non-Specific Interstitial, Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial
Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune
ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic
Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as
asbestosis with progressive phenotype.
Exclusion Criteria:
- Malignancy, treated or untreated, other than skin or early stage prostate cancer,
within the past 5 years.
- Currently listed for lung transplantation at the time of enrollment.
- Currently enrolled in a clinical trial at the time of enrollment in this registry
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Duke University
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Scott Palmer, MD
Principal Investigator Affiliation
Duke Clinical Research Institute, Duke University
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other, Industry
Overall Status
Recruiting
Countries
Puerto Rico, United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry
: Subjects with a non-IPF ILD diagnosis
Subjects with a diagnosis of a non-IPF ILD of any duration, including, but not limited to Idiopathic Non-Specific Interstitial Pneumonia (iNSIP), Unclassifiable Idiopathic Interstitial Pneumonias (IIPs), Interstitial Pneumonia with Autoimmune Features (IPAF), Autoimmune ILDs such as Rheumatoid Arthritis (RA-ILD) and Systemic Sclerosis (SSc-ILD), Chronic Hypersensitivity Pneumonitis (HP), Sarcoidosis or Exposure-related ILDs such as asbestosis with progressive phenotype
Interventions
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
University of Alabama - Birmingham, Birmingham, Alabama
