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Idiopathic Pulmonary FibrosisCOMETNCT01071707

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

An observational study of Idiopathic Pulmonary Fibrosis, run by University of Michigan at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
How many people
108 participants
Where
9 sitesUnited States
Study dates
Dec 2009to Aug 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

Who may be able to join

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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Brown University

    Providence, Rhode Island, 02903

  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

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 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.

Read the 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.

Keywords
IPF, Idiopathic Pulmonary Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01071707
Study groupRoleWhat they receive
Confirmed Diagnosis of IPFSubjects 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 IPFSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  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%.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionAug 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01071707
Sponsor's protocol ID
COMET
Other IDs
1RC2HL101740-01
Acronym
COMET
Status last verified
Nov 2009
First submitted
18 Feb 2010
Last updated
17 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35688625

  • 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.

    PubMed 34521729

  • 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.

    PubMed 28623539

  • 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.

    PubMed 24767767

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by University of Michigan at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01071707, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.

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