Correlating Outcomes With Biochemical Markers to Estimate Time-progression in Idiopathic Pulmonary Fibrosis (IPF) (COMET)
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90095
- University of California, Los Angeles
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San Francisco、California、美国、94143
- University of California, San Francisco
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Colorado
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Denver、Colorado、美国、80206
- National Jewish Medical and Research Center
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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19140
- Temple University
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Rhode Island
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Providence、Rhode Island、美国、02903
- Brown University
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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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%.
大体时间：Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks
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Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks
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合作者和调查者
调查人员
- 首席研究员：Galen B Toews, MD、University of Michigan
- 首席研究员：Kevin R Flaherty, MD, MS、University of Michigan
- 研究主任：Herbert Reynolds, MD、National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health
- 首席研究员：Fernando J Martinez, MD,MS、University of Michigan
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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. Erratum In: Lancet Respir Med. 2014 Aug;2(8):e14.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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