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

October 16, 2012 updated by: University of Michigan

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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 Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

Description

Inclusion Criteria:

  1. Suspected or confirmed diagnosis of IPF
  2. Age 35 - 80 years inclusive
  3. Ability to understand and provide informed consent

Exclusion Criteria:

  1. Confirmed diagnosis of IPF at the study center more than 4 years prior to screening
  2. Environmental exposure (occupational, environmental, drug, etc) felt by the principal investigator (PI) to be the etiology of the interstitial disease
  3. Diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
  4. Forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.60 at screening (postbronchodilator)
  5. Significant bronchodilator response on screening spirometry, defined as a change in FEV1 ≥ 12% and absolute change > 200 mL OR change in FVC ≥ 12% and absolute change > 200 mL
  6. Evidence of active infection at screening
  7. Listed for lung transplantation at time of screening
  8. Unstable or deteriorating cardiac disease at screening
  9. Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of screening
  10. Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of screening
  11. Uncontrolled arrhythmia at screening
  12. Severe uncontrolled hypertension at screening
  13. Known HIV or hepatitis C at screening
  14. Known cirrhosis or chronic active hepatitis at screening
  15. Active substance and/or alcohol abuse at screening
  16. Subjects who are pregnant or breastfeeding at screening
  17. Women of childbearing potential who are not using a medically approved means of contraception at screening
  18. Known bleeding abnormality that would preclude the performance of transbronchial lung biopsy
  19. Prothrombin time, INR > 1.5, Partial Thromboplastin Time (PTT) > 45 at time of screening, platelets < 100,000/mm3
  20. Any condition other than IPF that, in the opinion of the site PI, is likely to result in the death of the subject within the next year
  21. Any condition that, in the judgment of the site PI, might cause participation in this study to be detrimental to the subject or that the site PI deems makes the subject a poor candidate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Confirmed Diagnosis of IPF
Subjects in this cohort will continue beyond the screening visit(s) for longitudinal follow up visits for a minimum of 48 weeks and maximum of 80 weeks.
No diagnosis of IPF
Subjects that complete screening visits and do not obtain a confirmed diagnosis of IPF will conclude the study at screening, at the time point where IPF is ruled out as a diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome is progression free survival as determined by time until any of: death, acute exacerbation of IPF, relative change in FVC (liters) of at least 10% or DLCO (ml/min/mmHg) of 15%.
Time Frame: Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks
Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Galen B Toews, MD, University of Michigan
  • Principal Investigator: Kevin R Flaherty, MD, MS, University of Michigan
  • Study Director: Herbert Reynolds, MD, National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health
  • Principal Investigator: Fernando J Martinez, MD,MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 16, 2012

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMET
  • 1RC2HL101740-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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