Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation (INTERLUNG)

February 3, 2024 updated by: Philip Halloran, University of Alberta

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • The Alfred Hospital, Monash University
        • Contact:
        • Principal Investigator:
          • Glen Westall, MD, PhD
        • Principal Investigator:
          • Greg Snell, Professor
  • Austria
      • Vienna, Austria
        • Recruiting
        • Department of Thoracic Surgery, Medical University of Vienna
        • Contact:
          • Walter Klepetko, MD, PhD
          • Phone Number: +43-1-40400-5644
        • Principal Investigator:
          • Walter Klepetko, MD, PhD
        • Principal Investigator:
          • Peter Jaksch, MD, PhD
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • Alberta Transplant Applied Genomics Centre, University of Alberta
        • Contact:
        • Principal Investigator:
          • Philip F Halloran, MD, PhD
      • Edmonton, Alberta, Canada, T6G 2G3
        • Recruiting
        • Department of Medicine, University of Alberta
        • Contact:
        • Principal Investigator:
          • Kieran Halloran, MD
        • Sub-Investigator:
          • Justin Weinkauf, MD
        • Sub-Investigator:
          • Alim Hirji, MD
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network, Toronto General Hospital
        • Contact:
        • Principal Investigator:
          • Shaf Keshavjee, MD, MSc
        • Principal Investigator:
          • Stephen Juvet, MD, PhD
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Charles University/Hospital Motol
        • Contact:
        • Principal Investigator:
          • Jan Havlin, Dr
  • Poland
      • Szczecin, Poland, 70891
        • Recruiting
        • Thoracic Surgery Transplant Clinic
        • Contact:
        • Principal Investigator:
          • Bartosz Kupisa, PhD
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Suspended
        • University of Maryland School of Medicine
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Division of Pulmonary and Critical Care, Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Daniel Kreisel, MD, PhD
        • Sub-Investigator:
          • Elbert Trulock, MD, PhD
        • Sub-Investigator:
          • Ramsey Hachem, MD
    • Texas
      • San Antonio, Texas, United States, 21201
        • Recruiting
        • University of Texas at San Antonio
        • Contact:
        • Principal Investigator:
          • Deborah Jo Levine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.

Description

Inclusion Criteria:

  • All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.

Exclusion Criteria:

  • Patients who declined participation or unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
Time Frame: two years
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
two years
Report the molecular diagnoses of the MMDx-TBB system
Time Frame: two years
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
Time Frame: two years
Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
two years
Report the molecular diagnoses of the MMDx-3BMB system
Time Frame: two years
Compare MMDx-3BMB readings to MMDx-TBB readings and clinical diagnosis of CLAD
two years
Report the molecular changes over time in medically indicated follow-up biopsies
Time Frame: two years
Predict and monitor response to anti-rejection treatment.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Philip F Halloran, MD, PhD, Faculty of Medicine and Dentistry, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimated)

June 24, 2016

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATAGC 03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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