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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
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
1/06/2025
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/ct2/show/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.
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
konrad@ualberta.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02812290