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

16 octobre 2012 mis à jour par: University of Michigan

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Fibrose pulmonaire idiopatique

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

108

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

États-Unis
- California
  - Los Angeles, California, États-Unis, 90095
    - University of California, Los Angeles
  - San Francisco, California, États-Unis, 94143
    - University of California, San Francisco
- Colorado
  - Denver, Colorado, États-Unis, 80206
    - National Jewish Medical and Research Center
- Illinois
  - Chicago, Illinois, États-Unis, 60637
    - University of Chicago
- Michigan
  - Ann Arbor, Michigan, États-Unis, 48109
    - University of Michigan
- Ohio
  - Cleveland, Ohio, États-Unis, 44195
    - Cleveland Clinic Foundation
- Pennsylvania
  - Philadelphia, Pennsylvania, États-Unis, 19140
    - Temple University
- Rhode Island
  - Providence, Rhode Island, États-Unis, 02903
    - Brown University
- Tennessee
  - Nashville, Tennessee, États-Unis, 37232
    - Vanderbilt University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

35 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Délai
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%. Délai: Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks	Follow up visits after baseline, every 16 weeks for minimum of 40 weeks and maximum of 80 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Michigan

Collaborateurs

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

Les enquêteurs

Chercheur principal: Galen B Toews, MD, University of Michigan
Chercheur principal: Kevin R Flaherty, MD, MS, University of Michigan
Directeur d'études: Herbert Reynolds, MD, National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health
Chercheur principal: Fernando J Martinez, MD,MS, University of Michigan

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2009

Achèvement primaire (Réel)

1 août 2011

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

18 février 2010

Première soumission répondant aux critères de contrôle qualité