Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02758808
Study type Observational [Patient Registry]
Source Pulmonary Fibrosis Foundation
Contact
Status Completed
Phase
Start date March 29, 2016
Completion date December 16, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04497831 - Morphine for Dyspnea in Pulmonary Fibrosis Phase 3
Recruiting NCT05119972 - Tolerability, Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 1/Phase 2
Completed NCT01718990 - Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
Completed NCT00162760 - Treatment of Idiopathic Pulmonary Fibrosis With Thalidomide Phase 2
Terminated NCT04589260 - TD-1058 First-In-Human Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT04069143 - A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327 Phase 1
Completed NCT03050255 - Short-term Effects of Supplemental Oxygen in Patients With IPF N/A
Terminated NCT02013700 - Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER) Phase 1
Recruiting NCT04598919 - Saracatinib in the Treatment of Idiopathic Pulmonary Fibrosis Phase 1/Phase 2
Completed NCT03981094 - A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants Phase 1
Not yet recruiting NCT05387785 - Study to Assess the Safety and Tolerability of ANG-3070 in Subjects With Idiopathic Pulmonary Fibrosis Phase 1
Recruiting NCT05938920 - Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT02538536 - A Phase 2 Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT01371305 - STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Withdrawn NCT03720483 - Inhaled NAC in Treatment of IPF Phase 1/Phase 2
Recruiting NCT03478553 - The Genetics of Pulmonary Fibrosis
Completed NCT03650075 - To Determine Safety and Tolerability of MG-S-2525 and to Evaluate Its PK Profile in Healthy Volunteers Phase 1
Recruiting NCT05975983 - Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03832946 - A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT02874989 - Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial Phase 1