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

16 oktober 2012 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Idiopatisk lungfibros

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

108

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

35 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Individuals with suspected or confirmed diagnosis of Idiopathic Pulmonary Fibrosis

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
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%. Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Michigan

Samarbetspartners

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2009

Primärt slutförande (Faktisk)

1 augusti 2011

Avslutad studie (Faktisk)

1 augusti 2012

Studieregistreringsdatum

Först inskickad

18 februari 2010

Först inskickad som uppfyllde QC-kriterierna