Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF)
Completed
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
Study purpose: The disease course of idiopathic pulmonary fibrosis (IPF) is variable. During the course of the disease some patients will get better, some will stay the same, and others will get worse. Currently doctors do not have any way to predict an individual patients disease course. The purpose of this study is to determine if 'biomarkers' such as proteins or genes isolated at the time of diagnosis can be used to predict the disease course. These 'biomarkers' will be obtained from samples of blood, from a procedure call a bronchoscopy, and in some patients from extra tissue obtained by a surgical lung biopsy.
Key facts
- Study ID
- NCT01071707
- Run by
- University of Michigan
- People needed
- 108
- Starts
- 2009-12-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2012-10-17
Who can join
Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Suspected or confirmed diagnosis of IPF
- Age 35 - 80 years inclusive
- Ability to understand and provide informed consent
You may not qualify if…
- Confirmed diagnosis of IPF at the study center more than 4 years prior to screening
- Environmental exposure (occupational, environmental, drug, etc) felt by the principal investigator (PI) to be the etiology of the interstitial disease
- Diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
- Forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.60 at screening (postbronchodilator)
- Significant bronchodilator response on screening spirometry, defined as a change in FEV1 ≥ 12% and absolute change > 200 mL OR change in FVC ≥ 12% and absolute change > 200 mL
- Evidence of active infection at screening
- Listed for lung transplantation at time of screening
- Unstable or deteriorating cardiac disease at screening
- Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of screening
- Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of screening
- Uncontrolled arrhythmia at screening
- Severe uncontrolled hypertension at screening
- Known HIV or hepatitis C at screening
- Known cirrhosis or chronic active hepatitis at screening
- Active substance and/or alcohol abuse at screening
- Subjects who are pregnant or breastfeeding at screening
- Women of childbearing potential who are not using a medically approved means of contraception at screening
- Known bleeding abnormality that would preclude the performance of transbronchial lung biopsy
- Prothrombin time, INR > 1.5, Partial Thromboplastin Time (PTT) > 45 at time of screening, platelets < 100,000/mm3
- Any condition other than IPF that, in the opinion of the site PI, is likely to result in the death of the subject within the next year
- Any condition that, in the judgment of the site PI, might cause participation in this study to be detrimental to the subject or that the site PI deems makes the subject a poor candidate
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
- National Jewish Medical and Research Center — Denver, Colorado, United States
- University of Chicago — Chicago, Illinois, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Temple University — Philadelphia, Pennsylvania, United States
- Brown University — Providence, Rhode Island, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.