Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF) (COMET)
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| ClinicalTrials.gov Identifier: NCT01071707 |
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Recruitment Status :
Completed
First Posted : February 19, 2010
Last Update Posted : October 17, 2012
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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 or disease |
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| Idiopathic Pulmonary Fibrosis |
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 |
| Actual Enrollment : | 108 participants |
| 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 |
| Study Start Date : | December 2009 |
| Actual Primary Completion Date : | August 2011 |
| Actual Study Completion Date : | August 2012 |
| Group/Cohort |
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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.
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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.
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- 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 ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Suspected or confirmed diagnosis of IPF
- Age 35 - 80 years inclusive
- Ability to understand and provide informed consent
Exclusion Criteria:
- Confirmed diagnosis of IPF at the study center more than 4 years prior to screening
- Environmental exposure (occupational, environmental, drug, etc) felt by the principal investigator (PI) to be the etiology of the interstitial disease
- Diagnosis of collagen-vascular conditions (according to the published American College of Rheumatology criteria)
- Forced expiratory volume in 1 second (FEV1)/FVC ratio < 0.60 at screening (postbronchodilator)
- 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
- Evidence of active infection at screening
- Listed for lung transplantation at time of screening
- Unstable or deteriorating cardiac disease at screening
- Myocardial infarction, coronary artery bypass, or angioplasty within 6 months of screening
- Unstable angina pectoris or congestive heart failure requiring hospitalization within 6 months of screening
- Uncontrolled arrhythmia at screening
- Severe uncontrolled hypertension at screening
- Known HIV or hepatitis C at screening
- Known cirrhosis or chronic active hepatitis at screening
- Active substance and/or alcohol abuse at screening
- Subjects who are pregnant or breastfeeding at screening
- Women of childbearing potential who are not using a medically approved means of contraception at screening
- Known bleeding abnormality that would preclude the performance of transbronchial lung biopsy
- Prothrombin time, INR > 1.5, Partial Thromboplastin Time (PTT) > 45 at time of screening, platelets < 100,000/mm3
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071707
| 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 | |
| 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 |
| Responsible Party: | Fernando J. Martinez, MD, MS, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01071707 |
| Other Study ID Numbers: |
COMET 1RC2HL101740-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 19, 2010 Key Record Dates |
| Last Update Posted: | October 17, 2012 |
| Last Verified: | November 2009 |
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IPF Idiopathic Pulmonary Fibrosis |
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis |
Pathologic Processes Lung Diseases Respiratory Tract Diseases |