Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12623000596606
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
31/05/2023
Date last updated
31/05/2023
Date data sharing statement initially provided
31/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Oncology Search Clinical Assistant Registry: An evaluation study for matching molecular profiling results with treatments for paediatric oncology patients
Scientific title
Oncology Search Clinical Assistant Registry: An evaluation study for matching molecular profiling results with treatments for paediatric oncology patients
Secondary ID [1] 309423 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OSCAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Cancer 329678 0
Condition category
Condition code
Cancer 326576 326576 0 0
Children's - Other

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
OSCAR is a search engine designed to facilitate treatment matching for children with cancer who have undergone molecular profiling of their tumour tissue and germline.

This study aims to evaluate OSCAR using a two-phase approach:
1) An initial validation phase, using reports generated as part of the ZERO Childhood Cancer Program platform to validate and train the algorithm. Data collected during the validation phase will include the results generated by the search-engine, number of results and how many results match those found by manual searches; and
2) A user evaluation phase aiming to work alongside curation clinicians that will trial OSCAR and compare workload by using the search-engine, and provide qualitative reports of their user experience. Workload is defined by time spent performing treatment matching and user experience (OSCAR's ease of use, training time, etc).


The initial validation phase will be completed after all existing eligible reports have been used by the CSIRO to validate and train the OSCAR algorithm. It is estimated his process will take two to three months.
Intervention code [1] 325854 0
Not applicable
Comparator / control treatment
OSCAR search results will be compared to results generated by manual searches performed by curation clinicians as part of the ZERO Childhood Cancer Program. For the validation phase Molecular profiling reports were done from 2018 to 2023. For the User Validation phase reports will be prospectively obtained from patients enrolled in the ZERO2 study.

Manual searches are conducted using PubMed and clinicaltrials.gov.
Control group
Historical

Outcomes
Primary outcome [1] 334432 0
OSCAR’s validity and performance when tested on patient cases. This is a composite outcome. OSCAR’s validity will be tested using sensitivity and specificity measures. Rank-based testing will be used to determine if the most relevant references in OSCAR’s search results are located towards the top positions of the list.
Timepoint [1] 334432 0
Study outcome will be assessed following an action research approach. Retrospective data from stage 1 will be assessed immediately after anonymisation and submission to CSIRO. Prospective longitudinal data from stage 2 will be evaluated immediately after molecular reports are submitted to curation clinicians. Summary reports will be prepared within approximately every 3 months.
Primary outcome [2] 334433 0
Workload (time and perceived effort) differences between standard manual searches and OSCAR. Workload is a composite outcome. Time will be defined as the time spent by curation clinicians between entering search queries and obtaining and appropriate list of results, measured by the program timestamps. Perceived effort will be determined qualitatively and measured with a clinician questionnaire.
Timepoint [2] 334433 0
Completion of OSCAR STAGE 2 (around 1 year after study commencement).
Secondary outcome [1] 420917 0
Identification of potential missed treatments in manual searches. Missed treatments will be identified by comparing to the original treatment recommendations list in previous ZERO reports and determining if the list generated by OSCAR has found any relevant treatments that were not identified by manual searches. This process will be performed by curation clinicians.
Timepoint [1] 420917 0
At the end of Oscar Stage 1. Expected to happen around 2 months after study initiation at our site.

Eligibility
Key inclusion criteria
Eligibility criteria for Validation Phase:
Inclusion criteria
• Age less than or equal to 18 years old at the time of biospecimen collection for PRISM/ZERO/ZERO2 report.
• Subjects enrolled in PRISM/ZERO/ZERO2 with a final molecular profiling report.



Eligibility criteria for User Evaluation Phase:
Inclusion criteria
• Age less than or equal to18 years old at the time of consent for this study and at the time of biospecimen collection for PRISM/ZERO/ZERO2 report.
• Subjects can be enrolled in OSCAR at any time after their PRISM/ZERO/ZERO2 consent and before curation clinicians receive their molecular profiling results.

Note: PRISM/ZERO/ZERO2 reports are the molecular profiling reports generated by the Zero Childhood Cancer Program.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with inconclusive or indeterminate molecular profiling results due to poor tissue quality or any other issues related to tissues collection and/or laboratory testing.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data from this study will be analysed using quantitative and qualitative methods to determine OSCAR’s validity, quality and user’s evaluation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313618 0
Charities/Societies/Foundations
Name [1] 313618 0
Children's Hospital Foundation
Country [1] 313618 0
Australia
Funding source category [2] 313622 0
Government body
Name [2] 313622 0
Commonwealth Scientific and Industrial Research Organisation’s (CSIRO)
Country [2] 313622 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Children's Hospital Foundation
Address
Level 14/199 Grey St, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 315415 0
None
Name [1] 315415 0
Address [1] 315415 0
Country [1] 315415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312791 0
• Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 312791 0
Ethics committee country [1] 312791 0
Australia
Date submitted for ethics approval [1] 312791 0
17/04/2023
Approval date [1] 312791 0
03/05/2023
Ethics approval number [1] 312791 0
HREC/23/QCHQ/97245

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

Contacts
Principal investigator
Name 125934 0
Dr Natacha Omer
Address 125934 0
Queensland Children's Hospital, 501 Stanley St, South Brisbane QLD 4101
Country 125934 0
Australia
Phone 125934 0
+61 730681111
Fax 125934 0
Email 125934 0
[email protected]
Contact person for public queries
Name 125935 0
Natacha Omer
Address 125935 0
Queensland Children's Hospital, 501 Stanley St, South Brisbane QLD 4101
Country 125935 0
Australia
Phone 125935 0
+61 730681111
Fax 125935 0
Email 125935 0
[email protected]
Contact person for scientific queries
Name 125936 0
Bevan Koopman
Address 125936 0
CSIRO, 306 Carmody Rd, St Lucia QLD 4067
Country 125936 0
Australia
Phone 125936 0
+61732533635
Fax 125936 0
Email 125936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data might contain details about participant's genetic information that cannot be divulged. Our study team will not have access to any raw genetic data.


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.