Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
INTERLUNG
Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
1 other identifier
observational
700
5 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
November 20, 2025
November 1, 2025
10.1 years
May 31, 2016
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
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
Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.
two years
Secondary Outcomes (3)
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
two years
Report the molecular diagnoses of the MMDx-3BMB system
two years
Report the molecular changes over time in medically indicated follow-up biopsies
two years
Interventions
In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.
Eligibility Criteria
Patients with functioning lung transplant biopsied to determine their graft dysfunction or to confirm good function as per standard of care.
You may qualify if:
- All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.
You may not qualify if:
- Patients who declined participation or unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
St. Joseph's Hospital and Medical Center 350 West Thomas Road, Floor 8HLT
Phoenix, Arizona, 85013, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Division of Pulmonary and Critical Care, Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Texas at San Antonio
San Antonio, Texas, 21201, 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, T6G 2E1, Canada
Department of Medicine, University of Alberta
Edmonton, Alberta, T6G 2G3, Canada
University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Charles University/Hospital Motol
Prague, Czechia
Thoracic Surgery Transplant Clinic
Szczecin, 70891, Poland
Related Publications (9)
Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
PMID: 38819301BACKGROUNDHalloran KM, Parkes MD, Chang J, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Trulock E, Roux A, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Molecular assessment of rejection and injury in lung transplant biopsies. J Heart Lung Transplant. 2019 May;38(5):504-513. doi: 10.1016/j.healun.2019.01.1317. Epub 2019 Feb 6.
PMID: 30773443RESULTHalloran K, Parkes MD, Timofte I, Snell G, Westall G, Havlin J, Lischke R, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular T-cell-mediated rejection in transbronchial and mucosal lung transplant biopsies is associated with future risk of graft loss. J Heart Lung Transplant. 2020 Dec;39(12):1327-1337. doi: 10.1016/j.healun.2020.08.013. Epub 2020 Aug 26.
PMID: 32943286RESULTHalloran K, Parkes MD, Timofte IL, Snell GI, Westall GP, Hachem R, Kreisel D, Levine D, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Hirji A, Weinkauf J, Halloran PF. Molecular phenotyping of rejection-related changes in mucosal biopsies from lung transplants. Am J Transplant. 2020 Apr;20(4):954-966. doi: 10.1111/ajt.15685. Epub 2019 Dec 1.
PMID: 31679176RESULTParkes MD, Halloran K, Hirji A, Pon S, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. Transcripts associated with chronic lung allograft dysfunction in transbronchial biopsies of lung transplants. Am J Transplant. 2022 Apr;22(4):1054-1072. doi: 10.1111/ajt.16895. Epub 2021 Dec 16.
PMID: 34850543RESULTHalloran K, Mackova M, Parkes MD, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Lischke R, Zajacova A, Havlin J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran PF. The molecular features of chronic lung allograft dysfunction in lung transplant airway mucosa. J Heart Lung Transplant. 2022 Dec;41(12):1689-1699. doi: 10.1016/j.healun.2022.08.014. Epub 2022 Aug 27.
PMID: 36163162RESULTGauthier PT, Mackova M, Hirji A, Weinkauf J, Timofte IL, Snell GI, Westall GP, Havlin J, Lischke R, Zajacova A, Simonek J, Hachem R, Kreisel D, Levine D, Kubisa B, Piotrowska M, Juvet S, Keshavjee S, Jaksch P, Klepetko W, Halloran K, Halloran PF. Defining a natural killer cell-enriched molecular rejection-like state in lung transplant transbronchial biopsies. Am J Transplant. 2023 Dec;23(12):1922-1938. doi: 10.1016/j.ajt.2023.06.003. Epub 2023 Jun 7.
PMID: 37295720RESULTMackova M, Gauthier P, Chang J, Hirji A, Weinkauf J, Juvet S, Keshavjee S, Havlin J, Lischke R, Zajacova A, Snell G, Westall G, Halloran PF, Halloran K. Molecular biopsy features associated with baseline lung allograft dysfunction in a multicenter international cohort. J Heart Lung Transplant. 2025 Nov 14:S1053-2498(25)02394-0. doi: 10.1016/j.healun.2025.11.005. Online ahead of print.
PMID: 41242356RESULTHalloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.
PMID: 33595110DERIVED
Biospecimen
Lung transplant biopsies taken as per local standard of care.
Study Officials
- PRINCIPAL INVESTIGATOR
Philip F Halloran, MD, PhD
Faculty of Medicine and Dentistry, University of Alberta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Professor
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 24, 2016
Study Start
May 1, 2016
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
November 20, 2025
Record last verified: 2025-11