Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
COMET: Correlating Outcomes With Biochemical Markers to Estimate Time-progression in IPF. A Prospective, Multi-Center, Longitudinal Follow up Study of Subjects With Idiopathic Pulmonary Fibrosis
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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