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

16 oktober 2012 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Idiopathische longfibrose

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

108

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

35 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
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%. Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Medewerkers

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

Onderzoekers

Hoofdonderzoeker: Galen B Toews, MD, University of Michigan
Hoofdonderzoeker: Kevin R Flaherty, MD, MS, University of Michigan
Studie directeur: Herbert Reynolds, MD, National Heart, Lung and Blood Institute, Division of Lung Sciences, National Institute of Health
Hoofdonderzoeker: Fernando J Martinez, MD,MS, University of Michigan

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2009

Primaire voltooiing (Werkelijk)

1 augustus 2011

Studie voltooiing (Werkelijk)

1 augustus 2012

Studieregistratiedata

Eerst ingediend

18 februari 2010

Eerst ingediend dat voldeed aan de QC-criteria