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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000929404p
Ethics application status
Submitted, not yet approved
Date submitted
28/07/2025
Date registered
27/08/2025
Date last updated
27/08/2025
Date data sharing statement initially provided
27/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
TRansplant and Infectious diseases Biobank and rEgistry (TRIBE)
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Scientific title
TRansplant and Infectious diseases Biobank and rEgistry (TRIBE)
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Secondary ID [1]
314782
0
None
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Universal Trial Number (UTN)
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Trial acronym
TRIBE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid organ transplantation
338013
0
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Transplant-related complications
338014
0
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Donor-derived infections
338017
0
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Stem cell transplantation
338446
0
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Transplant-related infections
338447
0
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Condition category
Condition code
Infection
334327
334327
0
0
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Other infectious diseases
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Surgery
334743
334743
0
0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
12
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Target follow-up type
Months
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Description of intervention(s) / exposure
The TRIBE is a multicenter clinical registry and biobank which will prospectively collect and store clinical data and samples from transplant recipients. Clinical data and high-quality stored biospecimens will be linked, allowing improvements in the delivery of clinical care and support for translational and basic science research.
TRIBE will collect the following data from transplant recipients: patient demographics, medical history, diagnoses leading to transplant, timing of transplant surgery, previous transplant history, donor details and post-transplant complications.
Samples that may be collected from transplant recipients include bloods, stool, urine, saliva, cerebrospinal fluid, bronchoscopy samples, colonoscopy samples and allograft biopsy samples.
In addition, TRIBE will collect clinical information about organ donors and link to enrolled participants for the purpose of reporting donor-derived infections. A waiver of consent will be sought for organ donors and clinical information about organ donors will be obtained via Donate Life Victoria (DLV).
For transplant recipients, there are two pathways to that data and/or samples can be submitted to the TRIBE: (1) routine collection of data and/or samples at pre-determined times (e.g. pre-transplant, >100 days post-transplant, >12 months post-transplant) and (2) event-driven collection of additional clinical data and/or samples [e.g. at time cytomegalovirus (CMV) disease is diagnosed].
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Intervention code [1]
331380
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
341986
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Rate of consent to contribute data and samples donation to TRIBE as a proportion of transplant recipients approached to participate in the active recruitment arm.
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Assessment method [1]
341986
0
Number of patients with data or samples collected will be determined by an audit of the study-specific electronic REDCap database.
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Timepoint [1]
341986
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Ongoing. Final analysis at study completion.
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Primary outcome [2]
341987
0
Rate of patients opting out of contributing data to TRIBE as a proportion of total transplants
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Assessment method [2]
341987
0
Audit of study-specific electronic REDCap database to count the number of patients with data collected
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Timepoint [2]
341987
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Ongoing. Final analysis at study completion.
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Primary outcome [3]
341988
0
Number and characteristics of people requesting data (i.e. transplant stream, scientific discipline, research institute)
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Assessment method [3]
341988
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Audit of the requests and provisions of data and/or samples to research projects included within the study-specific electronic REDCap database.
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Timepoint [3]
341988
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Ongoing. Final analysis at study completion.
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Secondary outcome [1]
450839
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Number of sites that have been successfully onboarded onto TRIBE
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Assessment method [1]
450839
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Audit of the study-specific electronic REDCap database to determine the number of sites agreed to join the TRIBE
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Timepoint [1]
450839
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Ongoing. Final analysis at study completion.
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Secondary outcome [2]
450840
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Number of instances TRIBE data as used to inform quality improvement activities or policy
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Assessment method [2]
450840
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Audit of the study-specific electronic REDCap database to determine the number of requests for data in order to inform quality improvement activities or policies
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Timepoint [2]
450840
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Ongoing. Final analysis at study completion.
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Eligibility
Key inclusion criteria
All transplant recipients.
Patients who are waitlisted or under evaluation for transplant.
All organ donors
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Minimum age
0
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
None
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
A range of statistical methods may be used depending on reporting requirements and quality audit activities. Descriptive characteristics of participants and audit metrics (i.e. consent rate, completeness of data) may be presented using median with interquartile range and frequency with percentage. Outcomes may be presented as count and percentage of all participants. Logistic regression may be used to compare those who have had a particular outcome compared to those who did not have the outcome.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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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
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
28156
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [2]
28157
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
44366
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3084 - Heidelberg
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Recruitment postcode(s) [2]
44367
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
319336
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Government body
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Name [1]
319336
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Austin Health Department of Infectious Diseases and Immunology Research Fund
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Address [1]
319336
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Country [1]
319336
0
Australia
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Funding source category [2]
319337
0
Charities/Societies/Foundations
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Name [2]
319337
0
Austin Health Foundation
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Address [2]
319337
0
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Country [2]
319337
0
Australia
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Primary sponsor type
Government body
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Name
Austin Health
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Address
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Country
Australia
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Secondary sponsor category [1]
321821
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None
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Name [1]
321821
0
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Address [1]
321821
0
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Country [1]
321821
0
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317918
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
317918
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
317918
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Australia
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Date submitted for ethics approval [1]
317918
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23/02/2024
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Approval date [1]
317918
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Ethics approval number [1]
317918
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Summary
Brief summary
Improvements to transplant outcomes are made possible through access to high quality clinical information and biological samples. Clinical information can be used to identify areas to improve patient care, inform clinical guidelines and to provide insights into problems about how to diagnose and treat diseases. The TRIBE aims to improve transplant outcomes by developing a transplant-related registry of clinical information linked with biological samples (e.g. blood, urine) which can be used to inform quality improvement activities and to support transplant-related research.
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Trial website
https://tribe-study.com/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
142550
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Dr Olivia Smibert
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Address
142550
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Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
142550
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Australia
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Phone
142550
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+613 9496 6676
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Fax
142550
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Email
142550
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[email protected]
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Contact person for public queries
Name
142551
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Olivia Smibert
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Address
142551
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Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
142551
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Australia
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Phone
142551
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+613 9496 6676
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Fax
142551
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Email
142551
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[email protected]
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Contact person for scientific queries
Name
142552
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Olivia Smibert
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Address
142552
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Austin Hospital, 145 Studley Road Heidelberg VIC 3084
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Country
142552
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Australia
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Phone
142552
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+613 9496 6676
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Fax
142552
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Email
142552
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Data may be requested by researchers based at universities, institutions, or companies located in Australia or internationally. Requests are reviewed according to the following criteria: (a) In order to be considered, the project for which data are requested must have ethics approval from a nationally or internationally accredited Human Research Ethics Committee (HREC). (b) Applications for data must be complete (TRIBE Data and Sample Access Form) and the information provided to TRIBE must be consistent with the information presented in the applicants’ HREC application. (c) The research protocol should align with the ethical, legal and practical considerations as stated in TRIBE How to Apply and Condition of Use policy.
Conditions for requesting access:
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Access to TRIBE data will only be provided if the TRIBE Data and Sample Access Committee approves the request, the proposed research project has received appropriate ethical approval and a Data Transfer Agreement has been fully executed (for researchers from institutions other than Austin Health).
What individual participant data might be shared?
•
De-identified individual participant data:
What types of analyses could be done with individual participant data?
•
Analyses as outlined in the approved Human Research Ethics Application and the TRIBE Data and Sample Application Form.
When can requests for individual participant data be made (start and end dates)?
From:
Time of study commencement
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Request submitted in writing to
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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