Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02151435

Enrollment

Registered

2014-05-30

Start date

2013-08-31

Completion date

2017-07-31

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPF

Keywords

Idiopathic Pulmonary Fibrosis, Biomarkers, Forced Vital Capacity, Diffusion Capacity for Carbon Monoxide, Prognosis

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age 35-80 years, inclusive 2. Diagnosis of IPF by HRCT or surgical lung biopsy 3. Able to understand and provide informed consent

Exclusion criteria

1. AE-IPF during the prior year 2. Environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease. 3. Diagnosis of collagen-vascular conditions according to published American College of Rheumatology criteria. 4. 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 5. Partial pressure of arterial oxygen (PaO2) \< 55 mm Hg 6. Evidence of active infection 7. Listed for lung transplantation 8. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months 9. Unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months 10. Uncontrolled arrhythmia or hypertension 11. Known HIV, hepatitis C, cirrhosis, or chronic active hepatitis 12. Active substance and/or alcohol abuse 13. If you are pregnant or breastfeeding 14. Any condition other than IPF that is likely to result in your death within the next year 15. 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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival	1 year	The primary outcome is your progression free survival as determined by time until any of: death, acute exacerbation of IPF, relative decline in FVC (liters) of at least 10% or DLCO (ml/min/mmHg) of 15% from baseline.

Other

Measure	Time frame	Description
Longitudinal change in biomarker levels	1 year	In exploratory analyses, longitudinal change in your biomarker expression will be correlated with your disease progression to determine if change in biomarker levels over time predict subsequent disease progression.

Countries

United States

Outcome results