NCT01915511 Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
| NCT ID | NCT01915511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2014-06 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2014-06 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Idiopathic Pulmonary Fibrosis Prospective Outcomes (IPF-PRO) Registry started recruiting in 2014 with the objective of studying Idiopathic Pulmonary Fibrosis. In 2018, the registry expanded to include recruitment of participants with other chronic fibrosing interstitial lung diseases (ILDs) with progressive phenotype also referred to as progressive fibrosing interstitial lung diseases in the Chronic Fibrosis Interstitial Lung Disease with Progressive Phenotype (ILD-PRO) Registry. When the third phase of the registry begins, the IPF-PRO registry will enroll additional patients with idiopathic pulmonary fibrosis. This IPF-PRO registry is a prospective registry that will collect information regarding the natural history, health care interactions, participant reported questionnaire data to assess quality of life, and the methods of treatment of participants with a diagnosis of idiopathic pulmonary fibrosis (IPF) or of another chronic fibrosing interstitial lung disease (ILD) with progressive phenotype established at the enrolling centers. In addition, blood samples and chest image studies will be collected and banked for future research projects.
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide informed consent * Established a new diagnosis (within 12 months) of IPF by the enrolling center. * Age 21 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 during the last 24 months by the enrolling center that meets the following criteria: * Chronic fibrosing ILD as defined by reticular abnormality with traction bronchiectasis with or without honeycombing confirmed by chest HRCT scan and/or lung biopsy. * Progressive phenotype as defined by fulfilling at least one of the criteria below of fibrotic changes (progression set point) within the last 24 months regardless of treatment considered appropriate in individual ILDs (8): * decline in FVC % predicted (% pred) based on ≥10% relative decline * decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with worsening of respiratory symptoms as assessed by the site investigator * decline in FVC % pred based on ≥5 - \<10% relative decline in FVC combined with increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator * decline in DLCO % pred based on≥ 10% relative decline * worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging (HRCT scan) as assessed by the site investigator independent of FVC change. The relative decline for FVC % predicted is calculated using the formula: Relative Decline= (FVC % Pred (Reference)-FVC % Pred (Screening))/(FVC % Pred (Reference))×100%, where FVC % Pred (Reference) is the greatest measurement of FVC % predicted in the 24 months prior to screening and FVC % Pred (Screening) is the measurement of FVC % predicted at screening. The relative decline for DLCO % predicted is calculated using the formula: Relative Decline= (DLCO % Pred (Reference)-DLCO % Pred (Screening))/(DLCO % Pred (Reference))×100%, Where DLCO % Pred (Reference) is the greatest measurement of DLCO % Pred in the 24 months prior to screening and DLCO % Pred (Screening) is the measurement of DLCO % Pred at screening 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 an interventional clinical trial at the time of enrollment in this registry * For the additional IPF cohort of 1000 individuals, previous enrollment in this registry.
Contact & Investigator
Scott Palmer, MD
PRINCIPAL INVESTIGATOR
Duke Clinical Research Institute, Duke University
Frequently Asked Questions
Who can join the NCT01915511 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01915511 currently recruiting?
Yes, NCT01915511 is actively recruiting participants. Contact the research team at rosalia.blanco@duke.edu for enrollment information.
Where is the NCT01915511 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT01915511 clinical trial?
NCT01915511 is sponsored by Duke University. The principal investigator is Scott Palmer, MD at Duke Clinical Research Institute, Duke University. The trial plans to enroll 3,000 participants.