Trial Review

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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 information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000480482
Ethics application status
Approved
Date submitted
21/02/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Drug allergy diagnostics, immunology, genomics (DALE) - A prospective registry and biorepository
Scientific title
Drug allergy diagnostics, immunology, genomics (DALE) - A prospective registry and biorepository for patients with drug allergy
Secondary ID [1] 314035 0
None
Universal Trial Number (UTN)
Trial acronym
DALE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug allergy 336779 0
Condition category
Condition code
Inflammatory and Immune System 333269 333269 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
Patients with a reported drug allergy that have been reviewed clinically as an inpatient or outpatient at participating centres will be included in the registry through a waiver of consent, both retrospectively and prospectively. Demographic, medical history, allergy history and allergy testing results will be included. Participants may also be invited to participate actively by donating research samples including blood, skin biopsy, blister fluid for immunological analysis at baseline, 3 months and 12 months post-enrolment. These active participants will also be requested to complete the DrHy-Q at baseline and 12 months post-enrolment. Any pre-existing drug allergy data from the medical record will be reviewed and may be collected retrospectively.
Intervention code [1] 330616 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340841 0
The number of participants with a reported drug allergy included in the registry per year
Timepoint [1] 340841 0
Data will be reviewed annually until the closure of the registry
Secondary outcome [1] 445216 0
Nil
Timepoint [1] 445216 0
Not applicable

Eligibility
Key inclusion criteria
Patients with a reported drug allergy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The study is observational and exploratory; therefore, no sample size has been calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2025
Date of last participant enrolment
Anticipated
15/02/2035
Actual
Date of last data collection
Anticipated
14/02/2036
Actual
Sample size
Target
3000
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 318542 0
University
Name [1] 318542 0
The University of Melbourne
Country [1] 318542 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 320938 0
Hospital
Name [1] 320938 0
Austin Health
Address [1] 320938 0
Country [1] 320938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317142 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 317142 0
Ethics committee country [1] 317142 0
Australia
Date submitted for ethics approval [1] 317142 0
16/08/2024
Approval date [1] 317142 0
06/02/2025
Ethics approval number [1] 317142 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140142 0
Prof Jason Trubiano
Address 140142 0
Department of Infectious Diseases and Immunology, Austin Hospital, 145 Studley Road, Heidelberg VIC 3084
Country 140142 0
Australia
Phone 140142 0
+61 3 9496 6676
Fax 140142 0
Email 140142 0
[email protected]
Contact person for public queries
Name 140143 0
Fiona James
Address 140143 0
Department of Infectious Diseases and Immunology, Austin Hospital, 145 Studley Road, Heidelberg VIC 3084
Country 140143 0
Australia
Phone 140143 0
+61 3 9496 6676
Fax 140143 0
Email 140143 0
[email protected]
Contact person for scientific queries
Name 140144 0
Jason Trubiano
Address 140144 0
Department of Infectious Diseases and Immunology, Austin Hospital, 145 Studley Road, Heidelberg VIC 3084
Country 140144 0
Australia
Phone 140144 0
+61 3 9496 6676
Fax 140144 0
Email 140144 0
[email protected]

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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
13/02/2025
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [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.