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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02812290




Registration number
NCT02812290
Ethics application status
Date submitted
31/05/2016
Date registered
24/06/2016
Date last updated
5/08/2024

Titles & IDs
Public title
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
Scientific title
Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
Secondary ID [1] 0 0
ATAGC 03
Universal Trial Number (UTN)
Trial acronym
INTERLUNG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Lung transplant biopsy bites.

Treatment: Surgery: Lung 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
Timepoint [1] 0 0
two years
Primary outcome [2] 0 0
Report the molecular diagnoses of the MMDx-TBB system
Timepoint [2] 0 0
two years
Secondary outcome [1] 0 0
Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
Timepoint [1] 0 0
two years
Secondary outcome [2] 0 0
Report the molecular diagnoses of the MMDx-3BMB system
Timepoint [2] 0 0
two years
Secondary outcome [3] 0 0
Report the molecular changes over time in medically indicated follow-up biopsies
Timepoint [3] 0 0
two years

Eligibility
Key inclusion criteria
* All lung transplant recipients undergoing a biopsy as determined by their surgeon or physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who declined participation or unable to give informed consent.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Alfred Hospital, Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Poland
State/province [8] 0 0
Szczecin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02812290
Trial related presentations / publications
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.
Halloran 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.
Halloran 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.
Halloran 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.
Parkes 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.
Halloran 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.
Gauthier 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.
Halloran 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.
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD, PhD
Address 0 0
Faculty of Medicine and Dentistry, University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Konrad S Famulski, PhD
Address 0 0
Country 0 0
Phone 0 0
1 780 492 1725
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02812290