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 : September 16, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Molecular Diagnosis of Idiopathic Interstitial Pneumonias: a Prospective Study|
|Actual Study Start Date :||June 28, 2019|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2025|
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
- 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
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, PhDfirstname.lastname@example.org|
|Contact: Karishma Hosein, MScemail@example.com|
|Principal Investigator:||Marco Mura, MD, PhD||Western University|