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

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ClinicalTrials.gov Identifier: NCT01071707
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : October 17, 2012
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Information provided by:
University of Michigan

Tracking Information
First Submitted Date February 18, 2010
First Posted Date February 19, 2010
Last Update Posted Date October 17, 2012
Study Start Date December 2009
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01071707 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF)
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
Brief Summary

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.

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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood, tissue
Sampling Method Non-Probability Sample
Study Population Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis
Condition Idiopathic Pulmonary Fibrosis
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2012)
108
Original Estimated Enrollment
 (submitted: February 18, 2010)
135
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01071707
Other Study ID Numbers COMET
1RC2HL101740-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fernando J. Martinez, MD, MS, University of Michigan
Study Sponsor University of Michigan
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
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
PRS Account University of Michigan
Verification Date November 2009