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Molecular Diagnosis of Idiopathic Interstitial Pneumonias: a Prospective Study

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ClinicalTrials.gov Identifier: NCT03836417
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:

Molecular diagnosis of idiopathic interstitial pneumonias is an innovative way to potentially improve the diagnostic accuracy of surgical lung biopsies (SLBs), introducing molecular classifiers of idiopathic pulmonary fibrosis (IPF) vs. non-specific interstitial pneumonia (NSIP), the 2 main types of idiopathic interstitial pneumonias (IIPs).

The investigators hypothesize that pre-defined gene expression profiles previously identified on large lung explants can still be identified and reproducible on smaller, clinically available surgical lung biopsies (SLBs), and can be used to increase diagnostic accuracy during multi-disciplinary discussion.

The investigators also hypothesize that the expression level of individual, preselected genes that accurately differentiate IPF from NSIP on lung explants can be reproduced on SLBs.

The investigators will isolate RNA from SLBs obtained from patients with IIP and perform microarray analysis to verify the reproducibility of gene expression profiles on SLBs. Individual genes expression levels will be determined by RT-PCR.

The diagnosis will be determined by MDD and further validated by prospective follow-up of patients for a period of 3 years.

The investigators will assess the impact of molecular diagnostic techniques on interobserver agreement during multi-disciplinary discussion.

The investigators will prospectively follow the clinical course of patients after SLB for a period of 3 years to validate the diagnosis, and asses the diagnostic accuracy of molecular techniques.


Condition or disease Intervention/treatment
Idiopathic Interstitial Pneumonia Idiopathic Pulmonary Fibrosis Nonspecific Interstitial Pneumonia Diagnostic Test: Microarray analysis

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Diagnosis of Idiopathic Interstitial Pneumonias: a Prospective Study
Estimated Study Start Date : May 6, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2025


Group/Cohort Intervention/treatment
Idiopathic interstitial pneumonias
Patients with idiopathic interstitial pneumonias undergoing surgical lung biopsy
Diagnostic Test: Microarray analysis
Microarray analysis to identify gene expression profiles that distinguish IPF from NSIP




Primary Outcome Measures :
  1. Reproducibility of gene expression profiles on surgical lung biopsies [ Time Frame: February 2019-January 2022 ]
    Proportion of patients (% of the total) with reproducible predefined gene expression profiles of either IPF or NSIP on surgical lung biopsy.


Secondary Outcome Measures :
  1. Prognostic impact of gene expression profiles of IPF and NSIP [ Time Frame: February 2019-January 2025 ]
    Hazard ratios of IPF and NSIP gene expression profiles (categorical variables) towards 3-year survival from the time of biopsy

  2. Prognostic impact of selected genes expression levels [ Time Frame: February 2019-January 2025 ]
    Hazard ratios of gene expression levels of 6 selected genes (continuous variables) towards 3-year survival from the time of biopsy.


Biospecimen Retention:   Samples With DNA
Lung tissue biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
After ruling out known causes (connective tissue disease; occupational, environmental or domestic exposures; drug-induced lung toxicity) of interstitial lung disease, patients being referred for a surgical lung biopsy to clarify the diagnosis of IIP (IPF vs. NSIP) will be recruited in the study.
Criteria

Inclusion criteria:

  1. Chronic interstitial lung disease not caused by connective tissue disease, drug-induced toxicity or environmental occupational or domestic exposures. These criteria equal to a diagnosis of idiopathic interstitial pneumonia (IIP).
  2. High resolution chest CT scan not consistent with an idiopathic pulmonary fibrosis pattern, therefore requiring a surgical lung biopsy to clarify the exact diagnosis of IIP.
  3. No contraindications to undergo a surgical lung biopsy (advanced disease stage; significant cardiac disease; significant obesity; or associated pulmonary hypertension).
  4. Patient able to provide informed consent.

Exclusion criteria:

  1. Chronic interstitial lung disease caused by connective tissue disease, drug-induced toxicity or environmental occupational or domestic exposures.
  2. High resolution chest CT scan consistent with an idiopathic pulmonary fibrosis pattern, therefore not requiring a surgical lung biopsy.
  3. Contraindications to undergo a surgical lung biopsy (advanced disease stage; significant cardiac disease; significant obesity; or associated pulmonary hypertension).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836417


Contacts
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Contact: Marco Mura, MD, PhD 5196676744 marco.mura@lhsc.on.ca
Contact: Karishma Hosein, MSc 5196676744 karishma.hosein@lhsc.on.ca

Locations
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Canada, Ontario
London Health Science Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Marco Mura, MD, PhD    5196676744    marco.mura@lhsc.on.ca   
Contact: Karishma Hosein, MSc    5196676744    karishma.hosein@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Marco Mura, MD, PhD Western University

Publications:
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03836417     History of Changes
Other Study ID Numbers: 6156
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections