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Trial registered on ANZCTR


Registration number
ACTRN12620000376943
Ethics application status
Approved
Date submitted
2/03/2020
Date registered
18/03/2020
Date last updated
18/03/2020
Date data sharing statement initially provided
18/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
INHALE: Investigation of Health outcomes in Australian Lung cancer
Scientific title
INHALE: Investigation of Health outcomes in Australian Lung cancer
Secondary ID [1] 300694 0
Not applicable
Universal Trial Number (UTN)
Not appplicable
Trial acronym
INHALE
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 316504 0
Condition category
Condition code
Cancer 314749 314749 0 0
Lung - Mesothelioma
Cancer 314750 314750 0 0
Lung - Non small cell
Cancer 314751 314751 0 0
Lung - Small cell

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The follow up period is 5 years. No additional tests are required, the project will capture data from the medical record of patients with histological or cytological confirmed lung cancer, or patients with a high clinical suspicion of a lung cancer diagnosis, based on radiological findings. Information regarding the multi-disciplinary management of lung cancer will be collected, including surgery, radiotherapy, systemic therapy and palliative care in the routine clinical practice setting.
Intervention code [1] 317017 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323097 0
Clinical data collection of 1000 lung cancer patients to determine real world clinical outcomes and tumour characteristics in routine clinical practice. This outcome is being assessed by entry into medical records.
Timepoint [1] 323097 0
Data will be collected at up to 6 time points for a maximum of 5 years; diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Time point is at the end of the 5 year data collection period.
Secondary outcome [1] 380767 0
Treatment patters of patients diagnosed with lung cancer in routine clinical practice. This outcome is being assessed by entry into medical records.
Timepoint [1] 380767 0
Data will be collected at up to 6 time points for a maximum of 5 years; diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Time point is at the end of the 5 year data collection period.
Secondary outcome [2] 380768 0
Overall survival of patients diagnosed with Lung Cancer in Ausralia after treatment. This outcome is being assessed from each patients medical record
Timepoint [2] 380768 0
Data will be collected at up to 6 time points for a maximum of 5 years; diagnosis, surgery, surveillance, chemotherapy, radiotherapy and recurrence. Time point is at the end of the 5 year data collection period.

Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed diagnosis of lung cancer, or high clinical suspicion of a diagnosis of lung cancer based on radiological findings
2. Patients aged 18 years or above
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
In order to compare clinical outcomes across different subgroups, Kaplan-Meier survival curves will be defined from survival data and constructed using SAS® software. The stratified log rank test will be used to compare survival curves between different groups of participants. P-values of 0.05 will be considered significant. Due to the non-randomised nature of such comparisons propensity score techniques will be used to balance comparison groups according to baseline factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16046 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 16047 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 16048 0
Footscray Hospital - Footscray
Recruitment hospital [4] 16049 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 16050 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [6] 16051 0
Epworth Eastern Hospital - Box Hill
Recruitment postcode(s) [1] 29559 0
3128 - Box Hill
Recruitment postcode(s) [2] 29560 0
3050 - Parkville
Recruitment postcode(s) [3] 29561 0
3011 - Footscray
Recruitment postcode(s) [4] 29562 0
3084 - Heidelberg
Recruitment postcode(s) [5] 29563 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 305136 0
Commercial sector/Industry
Name [1] 305136 0
Amgen
Address [1] 305136 0
Level 7, 123 Epping Road
North Ryde
NSW 2113
Country [1] 305136 0
Australia
Funding source category [2] 305137 0
Commercial sector/Industry
Name [2] 305137 0
BMS
Address [2] 305137 0
Level 2, 4 Nexus Court
Mulgrave
VIC 3170
Country [2] 305137 0
Australia
Primary sponsor type
Other
Name
The Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 305496 0
None
Name [1] 305496 0
Address [1] 305496 0
Country [1] 305496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305506 0
Melbourne Health HREC
Ethics committee address [1] 305506 0
Office for Research
Level 2
South West
300 Grattan Street
Parkville, VIC 3050
Ethics committee country [1] 305506 0
Australia
Date submitted for ethics approval [1] 305506 0
27/11/2019
Approval date [1] 305506 0
24/01/2020
Ethics approval number [1] 305506 0

Summary
Brief summary
The purpose of this study is to collect and analyse how lung cancer is managed in Australia, and examine patient outcomes.
Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with lung cancer.
Study details:
Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. All enrolled patients will have clinical data collected for up to 5 years. Data captured will include presentation of the disease, surgical interventions, prescription of system therapies, and information regarding multidisciplinary management and outcomes of lung cancer in the routine clinical practice setting.
This registry will be used to help to describe the current practice patterns so that we can continue to improve the health outcomes of patients diagnosed with lung cancer in Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100602 0
Prof Peter Gibbs
Address 100602 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 100602 0
Australia
Phone 100602 0
+61 3 9345 2555
Fax 100602 0
Email 100602 0
peter.gibbs@mh.org.au
Contact person for public queries
Name 100603 0
Dr Ben Markman
Address 100603 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 100603 0
Australia
Phone 100603 0
+61 3 9345 2555
Fax 100603 0
Email 100603 0
markman.b@wehi.edu.au
Contact person for scientific queries
Name 100604 0
Dr Ben Markman
Address 100604 0
Gibbs Laboratory Systems Biology & Personalised Medicine The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 100604 0
Australia
Phone 100604 0
+61 3 9345 2555
Fax 100604 0
Email 100604 0
markman.b@wehi.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The primary aim of the study is to determine the characteristics and clinical outcomes of patients with newly diagnosed lung cancer in routine clinical practice. Therefore, aggregated reports will be more useful rather than individual reports.
What supporting documents are/will be available?
No other documents available
Summary results
No Results