Pulmonary Fibrosis Foundation Patient Registry (PFFR)
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| ClinicalTrials.gov Identifier: NCT02758808 |
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Recruitment Status :
Recruiting
First Posted : May 3, 2016
Last Update Posted : September 26, 2019
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| Tracking Information | |||||||||
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| 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 |
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.
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| Original Primary Outcome Measures |
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.
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| Change History | Complete list of historical versions of study NCT02758808 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood, plasma, PAXgene
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| 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 |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria: 1. Diagnosed with:
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| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
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| 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 |
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| Responsible Party | Cathie Spino, ScD, University of Michigan | ||||||||
| Study Sponsor | University of Michigan | ||||||||
| Collaborators | Pulmonary Fibrosis Foundation | ||||||||
| Investigators |
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| PRS Account | University of Michigan | ||||||||
| Verification Date | September 2019 | ||||||||