Diagnostic & Therapeutic Applications of Microarrays in Lung

Status Recruiting

Clinical Trial Summary

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

Clinical Trial Description

The current standard for biopsy-based diagnoses of dysfunction of lung transplants is the International Society of Heart and Lung Transplantation (ISHLT) classification applied to transbronchial biopsies, which represents an arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that this system produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. especially in relationship to the correct diagnosis of chronic lung allograft dysfunction is a pressing need. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype. The MMDx, developed first in kidney transplant biopsies with thoroughly established phenotypes, will now be adapted to lung transplant transbronchial biopsies (TBBs). Microarray analysis of lung allograft biopsy specimens will be compared to conventional allograft phenotyping, including clinical, physiologic, radiographic and histological assessment. The present study will use the MMDx™ system to assess and report TBBs, and validate and refine this system in 300 unselected prospectively collected lung TBBs. A subset of the study will examine the third bifurcation mucosal endobronchial biopsies (3BMBs) paired with TBBs from 50 patients to see if the safer 3BMBs can substitute for the TBB to be used by MMDx™. Due to a considerable interest and support from participating Centers, the study is further extended and collected 1009 TBBs and 595 3BMBs from 874 patients. The investigators plan to collect more TBBS and 3BMBs at the conclusion of this study. This this is the extension of the INTERLUNG study - INTERLUNGEX. ;

Study Design

Related Conditions & MeSH terms

Lung Transplant Rejection

Clinical Trial Details

NCT number	NCT02812290
Study type	Observational
Source	University of Alberta
Contact	Konrad S Famulski, PhD
Phone	1 780 492 1725
Email	konrad@ualberta.ca
Status	Recruiting
Phase
Start date	May 2016
Completion date	June 2025

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02441413` - Transplant Optimization Using Functional Imaging (TROFI)	N/A
Recruiting	`NCT05375149` - Exhaled Breath Particles in Lung Transplantation
Active, not recruiting	`NCT03967340` - PREdiction of Chronic LUng Allograft Dysfunction
Active, not recruiting	`NCT05260372` - Next Generation Sequencing to Detect Acute Rejection in Lung Transplant Patients.
Recruiting	`NCT06082037` - A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction	Phase 3
Recruiting	`NCT04714801` - Adipose Derived Mesenchymal Cell Treatment in Lungtransplantation	Phase 1/Phase 2
Active, not recruiting	`NCT05170425` - LAMBDA 002 (Lung Registry) Study
Completed	`NCT02474927` - Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation	Phase 2
Recruiting	`NCT05006742` - Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients	N/A
Not yet recruiting	`NCT03500575` - Extracorporeal Photopheresis in Lung Transplant Rejection for Cystic Fibrosis (CF) Patients	N/A
Withdrawn	`NCT03805178` - Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization	Phase 2
Completed	`NCT03359863` - Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction	Phase 2
Active, not recruiting	`NCT03656926` - Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)	Phase 3
Completed	`NCT01985412` - Genome Transplant Dynamics: Non-invasive Sequencing-based Diagnosis of Rejection
Completed	`NCT04234919` - Longitudinal Study of Cell Free DNA in Lung Transplant
Recruiting	`NCT04837339` - Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation	N/A
Recruiting	`NCT03090581` - Transbronchial Biopsies With Cryoprobe in Patients With Lung Transplantation.	N/A
Recruiting	`NCT06112951` - A Prospective Randomized Trial of ECP in Subclinical AMR	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation — INTERLUNG

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms