Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000026729
Ethics application status
Approved
Date submitted
3/12/2021
Date registered
13/01/2022
Date last updated
16/09/2022
Date data sharing statement initially provided
13/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Particle Therapy Clinical Quality Registry (ASPIRE) is a prospective, observational, longitudinal study of paediatric, adolescent, young adult and rare adult tumour patients from a select group of tumour streams treated with radiation therapy.
Scientific title
The Australian Particle Therapy Clinical Quality Registry (ASPIRE) is a prospective, observational, longitudinal study of paediatric, adolescent, young adult and rare adult tumour patients from a select group of tumour streams treated with radiation therapy. Comparing the long term toxicities of photon and proton radiation therapy.
Secondary ID [1] 305960 0
Nil known
Universal Trial Number (UTN)
U1111-1272-1683
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 324559 0
Condition category
Condition code
Cancer 322025 322025 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
The registry has set an initial accrual goal of 50 patients per year until the registry is collecting national data, then it is anticipated there will be 400 patients per year recruited with a total of 4,000 participants in 10 years.
There are no clinical interventions required for participants enrolled onto the registry. All enrolled participants will receive treatment, and follow-up care as pre-determined by their treating clinician, in accordance with the standard of care at the treating institution. All treatment interventions that participants receive will be recorded on the registry database from the patient medical record, including (but not necessarily limited to) surgery, immunotherapy and/or chemotherapy (systemic therapy), as part of the initial treatment regimen and any subsequent therapy. Follow up of outcomes, including disease response, treatment toxicities and any disease progression and or survival will be recorded from the patient medical record as that information becomes available. The Data Manager at each treating site will update the participant's status in the REDCap database yearly from the available medical record and may also contact the referring or treating clinician directly to obtain follow-up results as required.
Participants will remain on the registry and will be followed until death, withdrawal of consent, or the registry is terminated.
Data collected is part of routine follow up care provided by the participants treating institution and collected from the medical record. There is no anticipated participant input.
Intervention code [1] 322358 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329793 0
Treatment response and patient side effects from treatment as determined by yearly follow up and medical record data linkage from the treating institution.
Timepoint [1] 329793 0
Ongoing throughout life of registry
Secondary outcome [1] 403803 0
Yearly follow up and testing/measurement/management of organs most at risk, based on area treated with radiation treatment.
Timepoint [1] 403803 0
Ongoing throughout registry

Eligibility
Key inclusion criteria
All adult, AYA and paediatric patients diagnosed with an Medicare Benefit Schedule (MBS) approved tumour type, as outlined below, who are treated with radiotherapy will be eligible for recruitment.

MBS Eligible Cancer Group
Base of Skull Meningioma
Chordoma
Chondrosarcoma
Tumour of the vertebral column or bony pelvis
Chordoma
Chondrosarcoma
Osteosarcoma
Ewing’s sarcoma of pelvis
Adenoid cystic carcinoma of the salivary or lacrimal gland
CNS
Medulloblastoma
Ependymoma
Glioma
Astrocytoma
Orbit, including retinoblastoma
Retinoblastoma
Axial skeleton or close proximity to axial skeleton, including bone or soft tissue sarcoma Ewing Sarcoma
Rhabdomyosarcoma
Osteosarcoma of axial skeleton
Craniopharyngioma
Intracranial germ cell tumour
Neuroblastoma
Nephroblastoma
Nephroblastoma - Wilm's
Minimum age
1 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on work completed for the MSAC 1638 application and the patient modelling and incidence rate data collected from 2015 and estimates made for 2025 population numbers provided to the Department of Health and Wellbeing and SA Health, there is an estimated national participant annual accrual onto the registry of:
• 180 > 25 years - Adult
• 233 < 25 years – Adolescent Young Adult (AYA)/Paediatric

The data collected in the registry will be used to describe the patterns of care and long-term toxicities for paediatric, AYA and rare adult cancer patients being treated with photon and or particle radiotherapy. As participation in the registry grows and the dataset matures, the intended use of the registry is to retrospectively determine the outcomes related to both disease and toxicities of photon treated cohorts in comparison to proton cohorts.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
27/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21272 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36142 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310299 0
Charities/Societies/Foundations
Name [1] 310299 0
The Hospital Research Foundation
Country [1] 310299 0
Australia
Primary sponsor type
Other
Name
The South Australian Health and Medical Research Institute (SAHMRI)
Address
North Terrace, Adelaide SA, 5000
Country
Australia
Secondary sponsor category [1] 311417 0
Other
Name [1] 311417 0
The Australian Bragg Centre for Proton Therapy and Research (ABCPTR)
Address [1] 311417 0
North Terrace, Adelaide SA, 5000
Country [1] 311417 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309962 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee
Ethics committee address [1] 309962 0
Ethics committee country [1] 309962 0
Australia
Date submitted for ethics approval [1] 309962 0
22/11/2021
Approval date [1] 309962 0
02/02/2022
Ethics approval number [1] 309962 0
2021/HRE00394: Australian Particle Therapy Clinical Quality Registry (APTCQR)

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

Contacts
Principal investigator
Name 116006 0
A/Prof Hien Le
Address 116006 0
C/O The South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide
SA 5000
Country 116006 0
Australia
Phone 116006 0
+61 08 7074 2432
Fax 116006 0
+61 08 7074 6211
Email 116006 0
hien.le@sa.gov.au
Contact person for public queries
Name 116007 0
Kelly Skelton
Address 116007 0
C/O The South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide
SA 5000
Country 116007 0
Australia
Phone 116007 0
+61 0881284480
Fax 116007 0
Email 116007 0
kelly.skelton@sahmri.com
Contact person for scientific queries
Name 116008 0
Kelly Skelton
Address 116008 0
C/O The South Australian Health and Medical Research Institute (SAHMRI)
North Terrace, Adelaide
SA 5000
Country 116008 0
Australia
Phone 116008 0
+61 0881284480
Fax 116008 0
Email 116008 0
kelly.skelton@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data aggregate will be shared


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.