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
ACTRN12625000038493
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA)
Scientific title
AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA)
Secondary ID [1] 313524 0
none
Universal Trial Number (UTN)
U1111-1316-5090
Trial acronym
AURORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic Cancers 335960 0
Non-small-cell lung cancer 335961 0
Small-cell lung cancer 335962 0
Mesothelioma 335963 0
Thymic Carcinoma 335964 0
Thymoma 335965 0
Condition category
Condition code
Cancer 332548 332548 0 0
Lung - Non small cell
Cancer 332549 332549 0 0
Lung - Small cell
Cancer 332550 332550 0 0
Lung - Mesothelioma
Cancer 332551 332551 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
This observational, longitudinal cohort study aims to collect comprehensive data on diagnostics, treatments, and clinical outcomes for individuals with thoracic cancers receiving care at participating Australian hospitals. Participants may be enrolled at diagnosis, upon referral to a participating centre, or at any stage of their treatment journey. For those enrolled post-diagnosis, prior treatments and diagnostic information including initial diagnosis date, are collected retrospectively. Follow-up is conducted until death or loss to follow-up. Data collection occurs approximately every 3 to 6 months, aligned with standard care follow-up or sub-study schedules. For retrospective studies, data collection may occur at a single time point. The study comprises two distinct cohorts:

Cohort A (Main Cohort): Patients are prospectively enrolled and have the option to provide consent for the collection of longitudinal blood and tissue samples, patient-reported outcomes, and access to health service data from the Pharmaceutical Benefits Scheme (PBS) and Medical Benefits Scheme (MBS). Participation is designed to enable a more comprehensive understanding of patient experiences and outcomes over time.

Cohort B (Clinical Cohort): Standard-care clinical data are collected under a waiver of consent, allowing for the inclusion of a broader patient population and ensuring the representativeness of real-world clinical practice.

Data from all participants enrolled under previous protocol versions (Thoracic Malignancies Study [Peter Mac, 2012–2018] and Australian Registry and Biobank of Thoracic Cancers [Australian sites, 2018–2024]) are included in the study cohort with ongoing follow-up and data collection for living patients occurring under the current protocol. These protocols have been HREC-approved for inclusion without additional reconsent requirements. All data and follow-up records have been transferred to the current study protocol and database, with prior protocols now closed. Data collection under previous protocols aligns with the methods outlined in the current study, ensuring capture of diagnostics, treatments, and clinical outcomes.

Results publications from closed protocols:
Thoracic Malignancies Cohort:
Outcomes in KRAS G12C - https://pubmed.ncbi.nlm.nih.gov/32619782/
Platelets in KRAS - https://pubmed.ncbi.nlm.nih.gov/32535617/
Outcomes in oncogene tumours - https://pubmed.ncbi.nlm.nih.gov/28544061/
Surgically resected lung cancers - https://pubmed.ncbi.nlm.nih.gov/34012481/
IO response NSCLC - https://pubmed.ncbi.nlm.nih.gov/36572732/
Trial matching systems - https://pubmed.ncbi.nlm.nih.gov/32734161/
Comorbidity in NSCLC - https://pubmed.ncbi.nlm.nih.gov/26851495/
Prognostic models - https://pubmed.ncbi.nlm.nih.gov/28728168/
Prognostic models - https://pubmed.ncbi.nlm.nih.gov/28764629/

Australian Registry and Biobank of Thoracic Cancers:
Pembro in NSCLC - https://pubmed.ncbi.nlm.nih.gov/38705835/
Lurbinectedin in SCLC - https://pubmed.ncbi.nlm.nih.gov/38369719/
Primary care linked data - https://pubmed.ncbi.nlm.nih.gov/39001673/
IO in NSCLC with brain mets - https://pubmed.ncbi.nlm.nih.gov/38406805/
IO in Meso - https://pubmed.ncbi.nlm.nih.gov/38036250/
Lorlatinib in ALK - https://pubmed.ncbi.nlm.nih.gov/37077199/
Impower150 in oncogene tumours - https://pubmed.ncbi.nlm.nih.gov/36030187/
Ex20 outcomes and patterns of care - https://pubmed.ncbi.nlm.nih.gov/34127383/
ROS1 thromboembolism - https://pubmed.ncbi.nlm.nih.gov/32087434/
Osimertinib in leptomeningeal disease - https://pubmed.ncbi.nlm.nih.gov/34994604/
Intervention code [1] 330096 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable. The defined cohorts represent different consent pathways but are intended to be combined into a single cohort for analysis.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340069 0
Number of patients registered on AURORA with associated clinical diagnostic, treatment, and outcomes data collected.
Timepoint [1] 340069 0
Ongoing. Final analysis at study completion.
Secondary outcome [1] 442536 0
Number of patients registered on AURORA with consent for access to archival tissue and blood samples.
Timepoint [1] 442536 0
Ongoing. Final analysis at study completion.
Secondary outcome [2] 442537 0
Number of patients registered on AURORA with consent for linkage with health utilisation data from the Pharmaceutical Benefits Scheme (PBS) and Medical Benefits Scheme (MBS) data.
Timepoint [2] 442537 0
Ongoing. Final analysis at study completion.
Secondary outcome [3] 442538 0
Description of the molecular characteristics of patients registered on AURORA with non-squamous non-small cell lung cancer (NSCLC).
Timepoint [3] 442538 0
Ongoing. Final analysis at study completion.
Secondary outcome [4] 442539 0
Number of patients registered on AURORA with consent for collection of prospective blood samples for analysis/banking.
Timepoint [4] 442539 0
Ongoing. Final analysis at study completion.
Secondary outcome [5] 442542 0
Description of the types of treatment strategies used across all lines of treatment for all stages of disease including surgical interventions, systemic therapies, and radiotherapy.
Timepoint [5] 442542 0
Ongoing. Final analysis at study completion.
Secondary outcome [6] 442543 0
Progression-free survival (PFS)
Timepoint [6] 442543 0
Ongoing. Final analysis at study completion.
Secondary outcome [7] 442544 0
Overall survival (OS)
Timepoint [7] 442544 0
Ongoing. Final analysis at study completion.
Secondary outcome [8] 442545 0
Time on treatment (ToT)
Timepoint [8] 442545 0
Ongoing. Final analysis at study completion.
Secondary outcome [9] 442546 0
Time to next treatment (TTNT)
Timepoint [9] 442546 0
Ongoing. Final analysis at study completion.
Secondary outcome [10] 442547 0
Treatment Response
Timepoint [10] 442547 0
Ongoing. Final analysis at study completion.
Secondary outcome [11] 442548 0
Number and types of studies, audits, and clinical trials conducted within or facilitated by AURORA (composite outcome)
Timepoint [11] 442548 0
Ongoing. Final analysis at study completion.

Eligibility
Key inclusion criteria
Patients must satisfy criteria 1 and 2, or criteria 3 to be eligible:
1. Any patient with suspected or proven thoracic malignancies (including NSCLC, SCLC, mesothelioma, thymoma, thymic carcinoma, and carcinoid tumours)
2. Age 18 or older
3. Previously enrolled in the Thoracic Malignancies Study [Peter Mac, 2012–2018] or Australian Registry and Biobank of Thoracic Cancers [Australian sites, 2018–2024]

*Inclusion criteria 1 and 2, are consistent with eligibility under previous protocol versions (Thoracic Malignancies Study and Australian Registry and Biobank of Thoracic Cancers).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no specific exclusion criteria.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Descriptive statistics will used to summarise key patient, investigation, treatment and outcome data. Categorical variables will be summarised using frequency and percentage. Continuous variables will be summarised using mean, standard deviation (SD) and range; or median, interquartile range (IQR) and range as appropriate. Rates for binary and count outcomes will be presented as point estimates with associated 95% confidence intervals presuming an underlying exact Poisson, negative binomial and/or zero-inflated distribution as indicated. Time-to-event outcomes will be summarised and visualised using Kaplan-Meier estimates. Comparison of binary endpoints between key patient and treatment groups will be analysed using binomial regression, logistic regression and/or mixed effects regression as appropriate. Comparison of count outcomes will be analysed using fixed-effects and/or mixed effects Poisson or negative binomial model as indicated. Analysis of time-to-event outcomes will be compared using a log-rank test, fixed or mixed effects Cox (proportional hazard, marginal or accelerated failure time) as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2030
Actual
Date of last data collection
Anticipated
31/12/2035
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
Recruitment hospital [1] 27386 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 27387 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 27388 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 27389 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 27390 0
Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [6] 27391 0
Concord Repatriation Hospital - Concord
Recruitment hospital [7] 27393 0
Eastern Health - Box Hill
Recruitment hospital [8] 27394 0
Epworth Richmond - Richmond
Recruitment hospital [9] 27395 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [10] 27396 0
GenesisCare - St Leonards - St Leonards
Recruitment hospital [11] 27397 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [12] 27398 0
Liverpool Hospital - Liverpool
Recruitment hospital [13] 27399 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment hospital [14] 27400 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [15] 27401 0
The Prince Charles Hospital - Chermside
Recruitment hospital [16] 27402 0
Prince of Wales Hospital - Randwick
Recruitment hospital [17] 27403 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43499 0
3000 - Melbourne
Recruitment postcode(s) [2] 43500 0
3084 - Heidelberg
Recruitment postcode(s) [3] 43501 0
2148 - Blacktown
Recruitment postcode(s) [4] 43502 0
2560 - Campbelltown
Recruitment postcode(s) [5] 43503 0
2050 - Camperdown
Recruitment postcode(s) [6] 43504 0
2139 - Concord
Recruitment postcode(s) [7] 43506 0
3128 - Box Hill
Recruitment postcode(s) [8] 43507 0
3121 - Richmond
Recruitment postcode(s) [9] 43508 0
6150 - Murdoch
Recruitment postcode(s) [10] 43509 0
2065 - St Leonards
Recruitment postcode(s) [11] 43510 0
2010 - Darlinghurst
Recruitment postcode(s) [12] 43511 0
2170 - Liverpool
Recruitment postcode(s) [13] 43512 0
3175 - Dandenong
Recruitment postcode(s) [14] 43513 0
2086 - Frenchs Forest
Recruitment postcode(s) [15] 43514 0
4032 - Chermside
Recruitment postcode(s) [16] 43515 0
2031 - Randwick
Recruitment postcode(s) [17] 43516 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 318018 0
Other
Name [1] 318018 0
AURORA has no specific overall platform funders. Funding model combines in-kind support from participating organizations with dedicated funding for individual projects from diverse sources including government, philanthropic, academic, and industry.
Country [1] 318018 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 320319 0
None
Name [1] 320319 0
Address [1] 320319 0
Country [1] 320319 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316647 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 316647 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 316647 0
Australia
Date submitted for ethics approval [1] 316647 0
01/10/2024
Approval date [1] 316647 0
31/10/2024
Ethics approval number [1] 316647 0
HREC/17/PMCC/42

Summary
Brief summary
AURORA is an Australasian multisite observational cohort study and biobank study that is seeking to create a representative data set on the current cancer features, diagnostics, treatments and outcomes for people diagnosed with thoracic cancers.

Who is it for?
You may be eligible for this study if you are an adult who has suspected or positively been diagnosed with a thoracic cancer, including non-small cell lung cancer, small cell lung cancer, mesothelioma, thymoma, thymic carcinoma, and/or carcinoid tumours. If you are eligible for this study, you may be enrolled at diagnosis, upon referral to a participating centre, or at any stage of your cancer treatment journey.

Study details
Participants who choose to enrol in this study may be asked if they would like to provide blood and tissue samples, complete questionnaires about their symptoms, and permit access to health service data (from Medicare or the medicines/pharmacy database). These activities usually do not require additional study visits; instead, they will take place during regular appointments. Data about cancer and treatments will be collected as part of routine care follow-up, approximately every 3 to 6 months for as long as care is ongoing. As this is an observational study, participants will not be offered any non-standard of care treatments for their cancer.

Participants who have previously been involved in cancer studies (Thoracic Malignancies Study [Peter Mac, 2012–2018] or Australian Registry and Biobank of Thoracic Cancers [Australian sites, 2018–2024]) will have their data and follow-up transitioned to this study, which replaces the previous study protocols. The ethics committee has determined that no further action is required from participants for this transition to take place.

It is hoped that this study will allow clinicians and researchers to better understand thoracic cancers, how these are being treated and how patients are responding to their chosen cancer treatments in Australian clinical practice. It is hoped this information can then be used to identify the best diagnosis methods and the most effective treatments for the different types of thoracic cancer, which can then be used to provide better outcomes for future patients with thoracic cancer.
Trial website
Trial related presentations / publications
Public notes
The Australasian Longitudinal Cohort Study brings together and builds upon two earlier research initiatives: the Thoracic Malignancies Study (2012–2018) and the Australian Registry and Biobank of Thoracic Cancers (2018–2024). With updated ethical approval, the study will officially begin enrolling new participants in January 2025. By combining data from past participants with new enrolments, this study aims to create a comprehensive resource to improve outcomes for people with thoracic cancers.

Contacts
Principal investigator
Name 138526 0
Prof Benjamin Solomon
Address 138526 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 138526 0
Australia
Phone 138526 0
+61 3 8559 7887
Fax 138526 0
Email 138526 0
[email protected]
Contact person for public queries
Name 138527 0
A/Prof Marliese Alexander
Address 138527 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 138527 0
Australia
Phone 138527 0
+61 3 8559 6137
Fax 138527 0
Email 138527 0
[email protected]
Contact person for scientific queries
Name 138528 0
A/Prof Marliese Alexander
Address 138528 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
Country 138528 0
Australia
Phone 138528 0
+61 3 8559 6137
Fax 138528 0
Email 138528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Diagnostic, clinical and outcomes data.
When will data be available (start and end dates)?
Data may be requested from time of study commencement with no end date determined.
Available to whom?
Data may be requested by researchers, academics, industry, or other individuals/organisations, with each request reviewed for appropriateness on a case-by-case basis by the AURORA Chair and Steering Committee.
Available for what types of analyses?
Audits, studies, and clinical trials as agreed by individual request.
How or where can data be obtained?
Request submitted in writing to [email protected]


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.