Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF)

2014-08-27 03:15:48 | BioPortfolio


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.


The objectives of this study are as follows:

Specific Aim 1: Assemble a network of clinical centers to procure biologic samples from subjects with recently diagnosed IPF and follow these subjects for at least 48 weeks. Specific Aim 2: Correlate and integrate biologically plausible biomarkers of disease activity obtained from multiple compartments (SLB, BAL, TBB, blood) from the same subject with longitudinal measures of disease progression (change in forced vital capacity, change in diffusion capacity for carbon monoxide, acute exacerbation of pulmonary fibrosis, and death).

General Study Design This study will take place in two phases. During the first phase of the study we will identify and collect baseline specimens from subjects with either suspected or recently diagnosed (within 48 months) IPF. During the second phase of the study subjects with IPF will be followed from between 48 and 80 weeks. Subjects will be followed until the end of study (2 year grant award) or until they meet any part of a composite endpoint (death, acute exacerbation of IPF, relative decline in FVC of at least 10% or DLCO of 15%). This is a prospective cohort study. There is no treatment prescribed or studied as part of this prospective cohort study. Subjects are able to utilize any treatments prescribed by their physician, including participation in clinical trials as long as they are able to comply with the follow up schedule in this study.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Idiopathic Pulmonary Fibrosis


University of California, Los Angeles
Los Angeles
United States




University of Michigan

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:48-0400

Clinical Trials [2010 Associated Clinical Trials listed on BioPortfolio]

Pirfenidone for the Treatment of Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)

To assess the long-term safety and efficacy of oral pirfenidone in doses of up to 40 mg/kg/d in a limited number of patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF)

OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study

Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pu...

Evaluation of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through an IPF Registry

The purpose of this study is to create a database of demographics and samples in idiopathic pulmonary fibrosis.

Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis

Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antago...

Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis Using PET/CT

The investigators wish to evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with Idiopathic Pulmonary Fibrosis.

PubMed Articles [4262 Associated PubMed Articles listed on BioPortfolio]

Likelihood of pulmonary hypertension in patients with idiopathic pulmonary fibrosis and emphysema.

This study evaluated whether patients with combined pulmonary fibrosis and emphysema (CPFE) have an increased likelihood of pulmonary hypertension (PHT) when compared with idiopathic pulmonary fibrosi...

Predicting Outcomes in Idiopathic Pulmonary Fibrosis Using Automated CT Analysis.

To determine whether computer-derived computed tomography measures, specifically measures of pulmonary vessel-related structures, can better predict functional decline and survival in idiopathic pulmo...

Acupuncture for idiopathic pulmonary fibrosis: Protocol for a systematic review.

Patients with idiopathic pulmonary fibrosis (IPF) often suffer from progressive worsening of dyspnea and lung function. Although 2 drugs are now available for IPF treatment, many gaps are still to be ...

Statin Therapy and Outcomes in Trials of Nintedanib in Idiopathic Pulmonary Fibrosis.

Cardiovascular comorbidities are frequent in patients with idiopathic pulmonary fibrosis (IPF), and many patients with IPF receive treatment with statins to reduce cardiovascular risk.

Abnormal Bolus Reflux Is Associated With Poor Pulmonary Outcome in Patients With Idiopathic Pulmonary Fibrosis.

Gastroesophageal reflux (GER) is postulated to play a role in idiopathic pulmonary fibrosis (IPF). However, the value of objective GER measures in predicting IPF disease progression is unclear. We aim...

Medical and Biotech [MESH] Definitions

A group of interstitial lung diseases with no known etiology. There are several entities with varying patterns of inflammation and fibrosis. They are classified by their distinct clinical-radiological-pathological features and prognosis. They include IDIOPATHIC PULMONARY FIBROSIS; CRYPTOGENIC ORGANIZING PNEUMONIA; and others.

A common interstitial lung disease of unknown etiology, usually occurring between 50-70 years of age. Clinically, it is characterized by an insidious onset of breathlessness with exertion and a nonproductive cough, leading to progressive DYSPNEA. Pathological features show scant interstitial inflammation, patchy collagen fibrosis, prominent fibroblast proliferation foci, and microscopic honeycomb change.

A form of CARDIAC MUSCLE disease in which the ventricular walls are excessively rigid, impeding ventricular filling. It is marked by reduced diastolic volume of either or both ventricles but normal or nearly normal systolic function. It may be idiopathic or associated with other diseases (ENDOMYOCARDIAL FIBROSIS or AMYLOIDOSIS) causing interstitial fibrosis.

A process in which normal lung tissues are progressively replaced by FIBROBLASTS and COLLAGEN causing an irreversible loss of the ability to transfer oxygen into the bloodstream via PULMONARY ALVEOLI. Patients show progressive DYSPNEA finally resulting in death.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

More From BioPortfolio on "Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF)"

Quick Search


Relevant Topic

Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Searches Linking to this Trial