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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90095
- University of California, Los Angeles
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San Francisco、California、アメリカ、94143
- University of California, San Francisco
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Colorado
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Denver、Colorado、アメリカ、80206
- National Jewish Medical and Research Center
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Illinois
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Chicago、Illinois、アメリカ、60637
- University of Chicago
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19140
- Temple University
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Brown University
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
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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%.
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Galen B Toews, MD、University of Michigan
- 主任研究者：Kevin R Flaherty, MD, MS、University of Michigan
- スタディディレクター：Herbert Reynolds, MD、National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health
- 主任研究者：Fernando J Martinez, MD,MS、University of Michigan
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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