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 : October 19, 2021
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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 |
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Idiopathic Interstitial Pneumonia Idiopathic Pulmonary Fibrosis Nonspecific Interstitial Pneumonia | Diagnostic Test: Microarray analysis |

Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Molecular Diagnosis of Idiopathic Interstitial Pneumonias: a Prospective Study |
Actual Study Start Date : | June 28, 2019 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2025 |

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

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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 |
Inclusion criteria:
- 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).
- 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.
- No contraindications to undergo a surgical lung biopsy (advanced disease stage; significant cardiac disease; significant obesity; or associated pulmonary hypertension).
- Patient able to provide informed consent.
Exclusion criteria:
- Chronic interstitial lung disease caused by connective tissue disease, drug-induced toxicity or environmental occupational or domestic exposures.
- High resolution chest CT scan consistent with an idiopathic pulmonary fibrosis pattern, therefore not requiring a surgical lung biopsy.
- Contraindications to undergo a surgical lung biopsy (advanced disease stage; significant cardiac disease; significant obesity; or associated pulmonary hypertension).

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
Contact: Marco Mura, MD, PhD | 5196676744 | marco.mura@lhsc.on.ca | |
Contact: Karishma Hosein, MSc | 5196676744 | karishma.hosein@lhsc.on.ca |
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 |
Principal Investigator: | Marco Mura, MD, PhD | Western University |
Responsible Party: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT03836417 |
Other Study ID Numbers: |
6156 |
First Posted: | February 11, 2019 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Idiopathic Interstitial Pneumonias |
Hamman-Rich Syndrome Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |