RecruitingNCT02812290

Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation

Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies


Sponsor

University of Alberta

Enrollment

700 participants

Start Date

May 1, 2016

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study uses a molecular analysis system (the Molecular Microscope Diagnostic System, or MMDx) to examine biopsy tissue from lung transplant recipients to see whether genetic fingerprinting of the tissue can diagnose the cause of allograft dysfunction more accurately than current standard methods, which are known to be inconsistent. Better diagnosis is critical because wrong diagnoses can lead to harmful, inappropriate treatments. All adult lung transplant recipients who are already scheduled for a biopsy as part of their standard care at participating centers are eligible. Participation involves allowing an additional analysis of the standard biopsy tissue sample (transbronchial biopsy); in a subset of patients, a gentler surface biopsy (endobronchial mucosal biopsy) will also be evaluated. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELung transplant biopsy bites.

In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.


Locations(11)

St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT

Phoenix, Arizona, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Division of Pulmonary and Critical Care, Washington University School of Medicine

St Louis, Missouri, United States

University of Texas at San Antonio

San Antonio, Texas, United States

The Alfred Hospital, Monash University

Melbourne, Australia

Department of Thoracic Surgery, Medical University of Vienna

Vienna, Austria

Alberta Transplant Applied Genomics Centre, University of Alberta

Edmonton, Alberta, Canada

Department of Medicine, University of Alberta

Edmonton, Alberta, Canada

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Charles University/Hospital Motol

Prague, Czechia

Thoracic Surgery Transplant Clinic

Szczecin, Poland

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NCT02812290


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