None listed
Conditions
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.
Interventions
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. Follo
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/
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Exclusion criteria
There are no specific exclusion criteria.
Outcome results
None listed