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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01071707
First received: February 18, 2010
Last updated: October 16, 2012
Last verified: November 2009
  Purpose

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.


Condition
Idiopathic Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, tissue


Enrollment: 108
Study Start Date: December 2009
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071707

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02903
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
University of Michigan
Investigators
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
Principal Investigator: Galen B Toews, MD University of Michigan
Principal Investigator: Kevin R Flaherty, MD, MS University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando J. Martinez, MD, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT01071707     History of Changes
Other Study ID Numbers: COMET, 1RC2HL101740-01
Study First Received: February 18, 2010
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
IPF
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014