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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05184790




Registration number
NCT05184790
Ethics application status
Date submitted
22/12/2021
Date registered
11/01/2022

Titles & IDs
Public title
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
Scientific title
LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology
Secondary ID [1] 0 0
IX-2021-DS-LEARN
Universal Trial Number (UTN)
Trial acronym
LEARN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arrhythmias, Cardiac 0 0
Breast Cancer 0 0
Prostatic Cancer 0 0
Brain Cancer 0 0
Kidney Cancer 0 0
Head and Neck Cancer 0 0
Liver Cancer 0 0
Pancreatic Cancer 0 0
Spinal Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Prostate
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brain cancer - Patients having radiation therapy for treatment of brain cancer.

Breast cancer - Patients having radiation therapy for treatment of breast cancer.

Head and neck cancer - Patients having radiation therapy for treatment of head and neck cancer.

Kidney cancer - Patients having radiation therapy for treatment of kidney cancer.

Liver cancer - Patients having radiation therapy for treatment of liver cancer.

Pancreatic cancer - Patients having radiation therapy for treatment of pancreatic cancer.

Prostatic cancer - Patients having radiation therapy for treatment of prostate cancer.

Spinal neoplasm - Patients having radiation therapy for treatment of spinal cancer.

Cardiac arrhythmia - Patients having radiation therapy for treatment of cardiac arrhythmia
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Accuracy of markerless tracking
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Clinical acceptability of markerless tracking system
Timepoint [1] 0 0
3 years

Eligibility
Key inclusion criteria
* Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.
* Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.
* Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.
* Provides written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Less than 18 years of age

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
28/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Calvary Mater Newcastle, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Western Sydney Local Health District
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Austin Health
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Peter MacCallum Cancer Centre, Australia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Paul Keall
Address 0 0
Professor
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shona Silvester
Address 0 0
Country 0 0
Phone 0 0
+61 2 8627 1185
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After study completion, de-identified (non-coded, non-re-identifiable) data will be available to researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After study completion.
Available to whom?
Data stored at the university: In order to download / decompress the stored, de-identified data, participating researchers will agree to the terms of use for the data, including that the data are not to be published or otherwise redistributed without the express consent of the original investigator(s).

Data stored at an external repository: de-identified study data may be provided to an external research data repository, archive or register so that it may be made publicly available for other scientific research. Study data that are provided to an external research data repository will be stored at and managed by the external repository. Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05184790