Pulmonary Fibrosis Foundation Patient Registry (PFFR)
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|ClinicalTrials.gov Identifier: NCT02758808|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : August 15, 2022
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|Condition or disease|
|Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF)|
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]|
|Actual Enrollment :||2004 participants|
|Target Follow-Up Duration:||7 Years|
|Official Title:||Pulmonary Fibrosis Foundation Patient Registry|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 16, 2022|
|Estimated Study Completion Date :||October 2023|
- Change in % predicted FVC [ Time Frame: Up to 55 months ]Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
- Change in % predicted DLCO [ Time Frame: Up to 55 months ]Analysis of registry data will lead to aggregated reports summarizing the pulmonary function
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 99 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 18 years old or older
- Understand and sign the informed consent document
ILD Diagnosis must be made / confirmed at a participating Registry center.
- 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.
- If patients exhibit another pulmonary disease (such as emphysema or asthma), the primary disease must be ILD.
- Anticipated additional follow up at the Registry center within one year.
1. Diagnosed with:
- Lymphangioleiomyomatosis (LAM)
- Pulmonary alveolar proteinosis (PAP)
- Cystic fibrosis (CF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758808
|Study Chair:||Kevin R Flaherty, MD||University of Michigan|
|Principal Investigator:||Catherine A Spino, ScD||University of Michigan|
|Responsible Party:||Cathie Spino, ScD, Research Professor, University of Michigan|
|Other Study ID Numbers:||
|First Posted:||May 3, 2016 Key Record Dates|
|Last Update Posted:||August 15, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases