Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

Completed

Conditions studied: IPF

In brief

Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal, fibrotic disorder of the lung. The estimated prevalence is 30-80/100,000 in the United States with incidence estimates clearly rising. A major challenge in the care of patients with IPF is determining prognosis. The natural history of IPF is usually one of inexorable decline in lung function, ultimately resulting in death from respiratory failure. However, longitudinal physiologic decline in IPF is heterogeneous and difficult to predict in individual patients. While some patients with IPF may remain stable for years, in others the disease may progress rapidly over a relatively short time. We hypothesize that peripheral blood biomarkers based on extracellular matrix and matrix-modifying molecules will improve prognostication in patients with IPF.

Key facts

Study ID

NCT02151435

Run by

University of Michigan

People needed

43

Starts

2013-08-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-26

Who can join

Age: 35 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 35-80 years, inclusive
• Diagnosis of IPF by HRCT or surgical lung biopsy
• Able to understand and provide informed consent

You may not qualify if…

• AE-IPF during the prior year
• Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease.
• Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria.
• Significant airway obstruction (FEV1/FVC ratio < 0.60) or bronchodilator response, defined as a change in FEV1 ≥ 12% and absolute change > 200 mL OR change in FVC ≥ 12% and absolute change > 200 mL at baseline
• Partial pressure of arterial oxygen (PaO2) < 55 mm Hg
• Evidence of active infection
• Listed for lung transplantation
• Myocardial infarction, coronary artery bypass, or angioplasty within 6 months
• Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months
• Uncontrolled arrhythmia or hypertension
• Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis
• Active substance and/or alcohol abuse
• If you are pregnant or breastfeeding
• Any condition other than IPF that is likely to result in your death within the next year
• Any condition that, in the judgment of the PI, might cause participation in the study to be detrimental to you or that the PI deems makes you a poor candidate

Where it is running

• University of Michigan Medical Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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