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DEFINITIONS
Trial Review
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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)
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Scientific title
AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA)
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Secondary ID [1]
313524
0
none
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Universal Trial Number (UTN)
U1111-1316-5090
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Trial acronym
AURORA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thoracic Cancers
335960
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Non-small-cell lung cancer
335961
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Mesothelioma
335963
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Thymic Carcinoma
335964
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Small-cell lung cancer
335962
0
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Thymoma
335965
0
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Condition category
Condition code
Cancer
332550
332550
0
0
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Lung - Mesothelioma
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Cancer
332551
332551
0
0
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Other cancer types
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Cancer
332549
332549
0
0
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Lung - Small cell
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Cancer
332548
332548
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0
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Lung - Non small cell
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
10
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Target follow-up type
Years
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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/
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Intervention code [1]
330096
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Diagnosis / Prognosis
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Comparator / control treatment
Not applicable. The defined cohorts represent different consent pathways but are intended to be combined into a single cohort for analysis.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
340069
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Number of patients registered on AURORA with associated clinical diagnostic, treatment, and outcomes data collected.
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Assessment method [1]
340069
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Audit of cohort databank to count the number of patients with clinical data collected. The analysis will include overall numbers and stratification by thoracic cancer diagnosis and molecular sub-types.
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Timepoint [1]
340069
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Ongoing. Final analysis at study completion.
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Secondary outcome [1]
442536
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Number of patients registered on AURORA with consent for access to archival tissue and blood samples.
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Assessment method [1]
442536
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Audit of cohort databank to count the number of patients with archival tissue and blood consent. The analysis will include overall numbers and stratification by thoracic cancer diagnosis and molecular sub-types.
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Timepoint [1]
442536
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Ongoing. Final analysis at study completion.
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Secondary outcome [2]
442538
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Description of the molecular characteristics of patients registered on AURORA with non-squamous non-small cell lung cancer (NSCLC).
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Assessment method [2]
442538
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Audit of cohort databank to calculate the proportion of patients with non-squamous NSCLC who have: (1) undergone testing for targetable molecular subtypes and (2) been identified as harboring these subtypes. The analysis will include overall proportions and stratification by specific molecular subtypes (aligned with evolving recommendations for molecular testing) and by test timepoints including diagnostic and longitudinal biopsy data.
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Timepoint [2]
442538
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Ongoing. Final analysis at study completion.
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Secondary outcome [3]
442537
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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.
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Assessment method [3]
442537
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Audit of cohort databank to count the number of patients with PBS/MBS consent. The analysis will include overall numbers and stratification by thoracic cancer diagnosis and molecular sub-types.
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Timepoint [3]
442537
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Ongoing. Final analysis at study completion.
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Secondary outcome [4]
442544
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Overall survival (OS)
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Assessment method [4]
442544
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OS will be summarised and visualised using Kaplan-Meier estimates and compared between key clinical, molecular, and treatment subgroups using a log-rank test or Cox model as appropriate. It will be calculated as the time from the initial diagnosis or intervention (depending on the analysis context) to death by any cause. Patients who are lost to follow-up or remain alive at the time of analysis will be censored. Survival data is sourced directly from medical records and treating teams.
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Timepoint [4]
442544
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Ongoing. Final analysis at study completion.
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Secondary outcome [5]
442545
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Time on treatment (ToT)
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Assessment method [5]
442545
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ToT will be summarised and visualised using Kaplan-Meier estimates and compared between key clinical, molecular, and treatment subgroups using a log-rank test or Cox model as appropriate. It will be calculated as the time from treatment initiation to treatment cessation for any reason including toxicity or progression, Patients who are lost to follow-up or remain on treatment at the time of analysis will be censored. Data is sourced directly from medical records and treating teams.
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Timepoint [5]
442545
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Ongoing. Final analysis at study completion.
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Secondary outcome [6]
442546
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Time to next treatment (TTNT)
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Assessment method [6]
442546
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TTNT will be summarised and visualised using Kaplan-Meier estimates and compared between key clinical, molecular, and treatment subgroups using a log-rank test or Cox model as appropriate. It will be calculated as the time from treatment initiation of one line of therapy to treatment initiation of the next line of therapy, Patients who are lost to follow-up or have not commenced their next line of treatment at the time of analysis will be censored. Data is sourced directly from medical records and treating teams.
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Timepoint [6]
442546
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Ongoing. Final analysis at study completion.
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Secondary outcome [7]
442539
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Number of patients registered on AURORA with consent for collection of prospective blood samples for analysis/banking.
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Assessment method [7]
442539
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Audit of cohort databank to count the number of patients with prospective blood collection/banking. The analysis will include overall numbers and stratification by thoracic cancer diagnosis and molecular sub-types.
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Timepoint [7]
442539
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Ongoing. Final analysis at study completion.
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Secondary outcome [8]
442547
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Treatment Response
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Assessment method [8]
442547
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Treatment response will be categorised as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not assessed/not assessable (NA), based on real-world response assessments recorded by treating clinicians. These assessments will rely on clinical judgment rather than formal, prospective RECIST criteria. Responses will be summarised using: Overall Response Rate (ORR): The proportion of patients achieving CR or PR among all patients with response assessments in the relevant disease subgroup. Disease Control Rate (DCR): The proportion of patients achieving CR, PR, or SD among all patients with response assessments in the relevant disease subgroup.
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Timepoint [8]
442547
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Ongoing. Final analysis at study completion.
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Secondary outcome [9]
442543
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Progression-free survival (PFS)
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Assessment method [9]
442543
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PFS will be summarised and visualised using Kaplan-Meier estimates and compared between key clinical, molecular, and treatment subgroups using a log-rank test or Cox model as appropriate. It will be defined as real-world PFS recorded by treating clinicians. This measure will rely on clinical judgment rather than formal, prospective RECIST assessments. PFS will be calculated as the time from the initial diagnosis or intervention (depending on the analysis context) to the first documented disease progression or death. Patients who are lost to follow-up or remain alive without documented progression at the time of analysis will be censored. Survival data is sourced directly from medical records and treating teams.
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Timepoint [9]
442543
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Ongoing. Final analysis at study completion.
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Secondary outcome [10]
442548
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Number and types of studies, audits, and clinical trials conducted within or facilitated by AURORA (composite outcome)
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Assessment method [10]
442548
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Audit of AURORA data requests tracking the number and types of studies or clinical trials initiated using AURORA data and/or samples. This information will be prospectively recorded by project administrators and reported both overall and stratified by study type.
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Timepoint [10]
442548
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Ongoing. Final analysis at study completion.
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Secondary outcome [11]
442542
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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.
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Assessment method [11]
442542
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Aggregate analysis of clinical data entries to identify treatment strategies used.
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Timepoint [11]
442542
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Ongoing. Final analysis at study completion.
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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).
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Minimum age
18
Years
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Maximum age
No limit
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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
There are no specific exclusion criteria.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Both
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/01/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2030
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Actual
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Date of last data collection
Anticipated
31/12/2035
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Actual
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Sample size
Target
10000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,WA,VIC
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Recruitment hospital [1]
27401
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
27389
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [3]
27387
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [4]
27388
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Blacktown Hospital - Blacktown
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Recruitment hospital [5]
27390
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Chris O’Brien Lifehouse - Camperdown
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Recruitment hospital [6]
27386
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [7]
27402
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Prince of Wales Hospital - Randwick
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Recruitment hospital [8]
27393
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Eastern Health - Box Hill
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Recruitment hospital [9]
27391
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Concord Repatriation Hospital - Concord
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Recruitment hospital [10]
27398
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Liverpool Hospital - Liverpool
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Recruitment hospital [11]
27403
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [12]
27394
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Epworth Richmond - Richmond
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Recruitment hospital [13]
27395
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [14]
27400
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The Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [15]
27396
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GenesisCare - St Leonards - St Leonards
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Recruitment hospital [16]
27399
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Dandenong Hospital- Monash Health - Dandenong
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Recruitment hospital [17]
27397
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment postcode(s) [1]
43510
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
43508
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6150 - Murdoch
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Recruitment postcode(s) [3]
43509
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2065 - St Leonards
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Recruitment postcode(s) [4]
43499
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3000 - Melbourne
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Recruitment postcode(s) [5]
43515
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2031 - Randwick
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Recruitment postcode(s) [6]
43501
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2148 - Blacktown
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Recruitment postcode(s) [7]
43502
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2560 - Campbelltown
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Recruitment postcode(s) [8]
43507
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3121 - Richmond
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Recruitment postcode(s) [9]
43516
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4102 - Woolloongabba
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Recruitment postcode(s) [10]
43514
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4032 - Chermside
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Recruitment postcode(s) [11]
43500
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3084 - Heidelberg
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Recruitment postcode(s) [12]
43504
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2139 - Concord
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Recruitment postcode(s) [13]
43503
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2050 - Camperdown
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Recruitment postcode(s) [14]
43513
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2086 - Frenchs Forest
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Recruitment postcode(s) [15]
43511
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2170 - Liverpool
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Recruitment postcode(s) [16]
43506
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3128 - Box Hill
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Recruitment postcode(s) [17]
43512
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3175 - Dandenong
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Funding & Sponsors
Funding source category [1]
318018
0
Other
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Name [1]
318018
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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.
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Address [1]
318018
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Country [1]
318018
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Australia
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Primary sponsor type
Hospital
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Name
Peter MacCallum Cancer Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
320319
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None
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Name [1]
320319
0
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Address [1]
320319
0
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Country [1]
320319
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316647
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Peter MacCallum Cancer Centre Human Research Ethics Committee
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Ethics committee address [1]
316647
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https://www.petermac.org/research/doing-research-us/ethics-governance
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Ethics committee country [1]
316647
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Australia
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Date submitted for ethics approval [1]
316647
0
01/10/2024
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Approval date [1]
316647
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31/10/2024
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Ethics approval number [1]
316647
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HREC/17/PMCC/42
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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.
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Trial website
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Trial related presentations / publications
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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.
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Contacts
Principal investigator
Name
138526
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Prof Benjamin Solomon
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Address
138526
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Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
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Country
138526
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Australia
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Phone
138526
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+61 3 8559 7887
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Fax
138526
0
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Email
138526
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[email protected]
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Contact person for public queries
Name
138527
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A/Prof Marliese Alexander
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Address
138527
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Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
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Country
138527
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Australia
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Phone
138527
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+61 3 8559 6137
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Fax
138527
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Email
138527
0
[email protected]
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Contact person for scientific queries
Name
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A/Prof Marliese Alexander
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Address
138528
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Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne VIC 3000
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Country
138528
0
Australia
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Phone
138528
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+61 3 8559 6137
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Fax
138528
0
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Email
138528
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
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.
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
Diagnostic, clinical and outcomes data.
What types of analyses could be done with individual participant data?
•
Audits, studies, and clinical trials as agreed by individual request.
When can requests for individual participant data be made (start and end dates)?
From:
Data may be requested from time of study commencement with no end date determined.
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Request submitted in writing to
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
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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