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

NCT01071707 | Completed

• 2 other identifiers: COMET1RC2HL101740-01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 9

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

IPF; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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%.

  Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

You may qualify if:

• Suspected or confirmed diagnosis of IPF
• Age 35 - 80 years inclusive
• Ability to understand and provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (9)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Brown University

Providence, Rhode Island, 02903, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

• Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

  PMID: 35688625 DERIVED

• Whalen W, Buyukozkan M, Moore B, Moon JS, Dela Cruz CS, Martinez FJ, Choi AMK, Krumsiek J, Stout-Delgado H, Cho SJ. Association of circulating cell-free double-stranded DNA and metabolic derangements in idiopathic pulmonary fibrosis. Thorax. 2022 Feb;77(2):186-190. doi: 10.1136/thoraxjnl-2021-217315. Epub 2021 Sep 14.

  PMID: 34521729 DERIVED

• Galli JA, Panetta NL, Gaeckle N, Martinez FJ, Moore B, Moore T, Courey A, Flaherty K, Criner GJ; COMET investigators. Pneumothorax After Transbronchial Biopsy in Pulmonary Fibrosis: Lessons from the Multicenter COMET Trial. Lung. 2017 Oct;195(5):537-543. doi: 10.1007/s00408-017-0028-z. Epub 2017 Jun 16.

  PMID: 28623539 DERIVED

• Han MK, Zhou Y, Murray S, Tayob N, Noth I, Lama VN, Moore BB, White ES, Flaherty KR, Huffnagle GB, Martinez FJ; COMET Investigators. Lung microbiome and disease progression in idiopathic pulmonary fibrosis: an analysis of the COMET study. Lancet Respir Med. 2014 Jul;2(7):548-56. doi: 10.1016/S2213-2600(14)70069-4. Epub 2014 Apr 21.

  PMID: 24767767 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, tissue

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Herbert Reynolds, MD

  National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: October 17, 2012

Record last verified: 2009-11

Locations

US (9)