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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02812290
Registration number
NCT02812290
Ethics application status
Date submitted
31/05/2016
Date registered
24/06/2016
Date last updated
5/06/2024
Titles & IDs
Public title
Diagnostic and Therapeutic Applications of Microarrays in Lung Transplantation
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Scientific title
Multi-Centric Observational Study to Analyze the Diagnostic Molecular Features in the Clinical Setting of Lung Allograft Biopsies
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Secondary ID [1]
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ATAGC 03
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Universal Trial Number (UTN)
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Trial acronym
INTERLUNG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lung Transplant Rejection
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Report the molecular scores (probability) of lung transplant disease in a reference set of 600 transbronchial biopsies.
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Assessment method [1]
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Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
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Timepoint [1]
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two years
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Primary outcome [2]
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Report the molecular diagnoses of the MMDx-TBB system
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Assessment method [2]
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Compare MMDx readings to standard-of-care TBB histology and clinical diagnosis of CLAD.
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Timepoint [2]
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two years
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Secondary outcome [1]
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Report the molecular scores (probability) of lung transplant disease in a reference set of 600 mucosal endobronchial biopsies.
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Assessment method [1]
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Molecular classifier predicts antibody mediated and T cell mediated rejection, and chronic allograft dysfunction.
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Timepoint [1]
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two years
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Secondary outcome [2]
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Report the molecular diagnoses of the MMDx-3BMB system
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Assessment method [2]
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Compare MMDx-3BMB readings to MMDx-TBB readings and clinical diagnosis of CLAD
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Timepoint [2]
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two years
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Secondary outcome [3]
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Report the molecular changes over time in medically indicated follow-up biopsies
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Assessment method [3]
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Predict and monitor response to anti-rejection treatment.
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Timepoint [3]
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two years
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Eligibility
Key inclusion criteria
- All lung transplant recipients undergoing a biopsy as determined by their surgeon or
physician.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients who declined participation or unable to give informed consent.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2025
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Alfred Hospital, Monash University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Maryland
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
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Austria
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State/province [4]
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Vienna
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Czechia
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State/province [7]
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Prague
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Country [8]
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Poland
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State/province [8]
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Szczecin
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Alberta
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02812290
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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.
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Public notes
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Contacts
Principal investigator
Name
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Philip F Halloran, MD, PhD
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Address
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Faculty of Medicine and Dentistry, University of Alberta
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Konrad S Famulski, PhD
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Address
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Country
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Phone
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1 780 492 1725
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02812290
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