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Trial Review
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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
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Scientific title
Oncology Search Clinical Assistant Registry: An evaluation study for matching molecular profiling results with treatments for paediatric oncology patients
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Secondary ID [1]
309423
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
OSCAR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Cancer
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Condition category
Condition code
Cancer
326576
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0
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Children's - Other
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
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.
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Intervention code [1]
325854
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Not applicable
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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.
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Control group
Historical
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Primary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Completion of OSCAR STAGE 2 (around 1 year after study commencement).
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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At the end of Oscar Stage 1. Expected to happen around 2 months after study initiation at our site.
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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.
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Minimum age
0
Years
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Maximum age
18
Years
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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 with inconclusive or indeterminate molecular profiling results due to poor tissue quality or any other issues related to tissues collection and/or laboratory testing.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2023
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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
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Children's Hospital Foundation
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Address [1]
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Level 14/199 Grey St, South Brisbane QLD 4101
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Commonwealth Scientific and Industrial Research Organisation’s (CSIRO)
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Address [2]
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306 Carmody Rd, St Lucia QLD 4067
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Country [2]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Children's Hospital Foundation
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Address
Level 14/199 Grey St, South Brisbane QLD 4101
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315415
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Country [1]
315415
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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• Children’s Health Queensland Human Research Ethics Committee
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Ethics committee address [1]
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Level 7, 62 Graham Street
South Brisbane QLD 4101
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Ethics committee country [1]
312791
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Australia
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Date submitted for ethics approval [1]
312791
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17/04/2023
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Approval date [1]
312791
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03/05/2023
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Ethics approval number [1]
312791
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HREC/23/QCHQ/97245
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Summary
Brief summary
While many childhood cancers can be treated with standard therapies that have proved to be effective, in some cases, children with cancer might benefit from treatments that match their tumour characteristics. These treatments are known as personalised medicine. Information about personalised medicine for childhood cancer can be found in two main sources: clinical trials and medical literature. The process of determining the best drug, or combination of drugs, for a child can be challenging because there is an ever-growing collection of both of these sources. The process of sorting through hundreds of search results is very time consuming and requires highly specialised knowledge. This means that finding the best treatment can be a complex process, which can make it difficult to choose the best treatment for each child.
In this study, we are partnering with researchers in CSIRO to develop Oncology Search Clinical Assistant Registry (OSCAR), a search tool designed to help paediatric oncologist find personalised treatments for childhood cancer.
Study Details: What does participation in this research involve for my child?
A. Allowing your child’s Molecular Profiling results from ZERO2 to be used to evaluate OSCAR: Your consent will allow ZERO2 clinicians to use your child’s ZERO2 results to evaluate the OSCAR search-engine. Clinicians trying to find adequate treatment for your child will do side-by-side comparisons of results doing manual searches with results obtained using the OSCAR search-engine.
There are no costs associated with participating in this research project, nor will you or your child be paid.
Who is it for?
You may be eligible for this study if you are a child who has been diagnosed with cancer and has been enrolled on one of the studies led by the ZERO Childhood Cancer Program (ZERO2/PRISM).
We hope this study will:
• Compare the quality of results generated by OSCAR to results obtained by doing manual searches.
• Determine if OSCAR can help save time when searching for personalised treatments for childhood cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Natacha Omer
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Address
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Queensland Children's Hospital, 501 Stanley St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 730681111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Natacha Omer
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Address
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Queensland Children's Hospital, 501 Stanley St, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 730681111
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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
Name
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Dr Bevan Koopman
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Address
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CSIRO, 306 Carmody Rd, St Lucia QLD 4067
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Country
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Australia
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Phone
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+61732533635
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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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