IPF/ILD-PRONCT01915511
Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease Prospective Outcomes Registry
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Record History
The 50 most recent of 51 versions: 46 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗
- Notable Eligibility criteria expanded, about 15 words
- Primary endpoints: details revised at 3 of 5 entries
- Trial sites expanded: 47 → 50 locations
- Publications: 22 to 23
- Minor Trial sites expanded: 44 → 47 locationsv50
- Minor Site contacts updated at 1 of 44 sitesv49
- Minor Trial sites expanded: 41 → 44 locationsv48
- Minor Site details revised at 2 of 41 sitesv47
Show 41 earlier versionsHide 41 earlier versions
- Minor Study sites: 40 to 41v46
- Minor Site details revised at 10 of 40 sitesv45
- Minor Site details revised at 2 of 40 sitesv44
- Minor Study completion date: Jan 2028 to Jan 2031
- Site contacts updated at 5 of 40 sites
- Minor Site details revised at 3 of 40 sitesv41
- Minor Study sites: 39 to 40v40
- Minor Site details revised at 1 of 39 sitesv39
- Minor Study sites: 49 to 39v38
Notable Enrollment target: 2000 to 3000v37 Show 4 more changesShow less
- Eligibility criteria expanded, about 304 words
- Primary endpoints revised (5)
- Study description expanded, about 223 words
- Study arms: 2 to 3
- Minor Site details revised at 9 of 49 sitesv36
- Minor Site details revised at 6 of 49 sitesv35
- Minor Site contacts updated at 7 of 49 sitesv34
- Minor Study sites: 48 to 49v33
- Notable Primary and study completion dates: Jan 2025 to Jan 2028
- Study sites: 49 to 48
- Minor Study sites: 51 to 49v31
- Minor Site details revised at 20 of 51 sitesv30
- Minor Study sites: 50 to 51v28
- Minor Study sites: 49 to 50v27
- Minor Study sites: 48 to 49v26
- Minor Study sites: 47 to 48v25
- Notable Eligibility criteria revisedv24
- Minor Site details revised at 4 of 47 sitesv23
- Minor Study sites: 46 to 47v22
- Minor Site details revised at 1 of 46 sitesv20
- Minor Study sites: 45 to 46v19
- Minor Site details revised at 25 of 45 sitesv18
- Notable Trial status: Active, Not Recruiting to Recruiting
- Site details revised at 45 of 45 sites
- Notable Primary endpoints revised (5)
- Eligibility criteria shortened, about 1 word
- Primary and study completion dates pushed to Jan 2025
Notable Primary completion date: Aug 2021 to Nov 2024v15 Show 8 more changesShow less
- Eligibility criteria expanded, about 40 words
- Primary endpoints: 4 to 5
- Trial status: Recruiting to Active, Not Recruiting
- Enrollment target: 1500 to 2000
- Study sites: 32 to 45
- Study completion date: Sep 2021 to Dec 2024
- Study arms: 1 to 2
- Study title expanded, about 4 words
- Notable Eligibility criteria shortened, about 7 words
- Study sites: 18 to 32
- Minor Site contacts updated at 10 of 18 sitesv12
- Notable Start date: Apr 2014 to Jun 2014
- Eligibility criteria expanded, about 2 words
- Notable Enrollment target: 300 to 1500
- Primary completion date: May 2019 to Aug 2021
- Study completion date: Jun 2019 to Sep 2021
- Secondary endpoints: details revised at 2 of 2 entries
- Notable Eligibility criteria expanded, about 37 words
- Study sites: 17 to 18
- Minor Secondary endpoints: 3 to 2
- Site details revised at 5 of 17 sites
- Minor Study sites: 13 to 17v7
- Minor Study sites: 10 to 13v6
- Minor Study sites: 5 to 10v5
- Minor Study sites: 2 to 5v4
- Notable Trial status: Not Yet Recruiting to Recruiting
- Study sites: 0 to 2
- Notable Primary completion date: Oct 2018 to May 2019
- Start date: Oct 2013 to Apr 2014
- Study completion date: Dec 2018 to Jun 2019
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Data on natural history of IPF & non-IPF chronic fibrosing ILD
Timeframe: End of Study (3 years after last patient will be enrolled)
Data on current practice patterns for diagnosis of IPF & non-IPF chronic fibrosing ILD
Timeframe: End of Study (3 years after last patient will be enrolled)
Data on impact of IPF & non- IPF chronic fibrosing ILD on patient quality of life.
Timeframe: End of Study (3 years after last patient will be enrolled)
Blood samples for future research.
Timeframe: End of Study (3 years after last patient will be enrolled)
HRCT images for future research (for non-IPF chronic fibrosing ILD, and new IPF patients cohort)
Timeframe: End of Study (3 years after last patient will be enrolled)
Secondary (2)
Data on management practices compared to existing guidelines.
Data on center-specific practices on outcomes.
Arms and interventions
Subjects with a new IPF diagnosis
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
New Subjects with a new IPF diagnosis
Subjects with a new diagnosis of IPF established at the time of enrollment in the registry not previously enrolled in the registry.
Sites
50 sites in 1 country