Prospective Evaluation of Biomarker Profiles in Idiopathic Pulmonary Fibrosis

NCT02151435 | Completed

• 2 other identifiers: UM HUM00004076R01HL109118
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

IPF

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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.

  1 year

Other Outcomes (1)

• Longitudinal change in biomarker levels

  1 year

Study Arms (1)

Patients with IPF

Observation of longitudinal biomarkers in IPF patients

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects with IPF identified via the University of Michigan Interstitial Lung Disease Clinical-Radiologic-Pathologic Conference. The investigators will only enroll subjects in whom an IPF diagnosis is firmly established.

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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Brown University: collaborator

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood plasma obtained from individuals at 6-month intervals for up to 2 years

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric S White, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: August 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

US (1)