Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


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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
ACTRN12620000508976
Ethics application status
Approved
Date submitted
31/03/2020
Date registered
24/04/2020
Date last updated
24/04/2020
Date data sharing statement initially provided
24/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Defining the lung cancer patient population admitted to intensive care in Australia
Scientific title
Characteristics and outcomes of lung caner patients admitted to the ICU: An Australian perspective
Secondary ID [1] 300170 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
LCIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 315715 0
Critical illness 315716 0
Condition category
Condition code
Respiratory 314002 314002 0 0
Other respiratory disorders / diseases
Cancer 315179 315179 0 0
Lung - Non small cell
Cancer 315180 315180 0 0
Lung - Small cell
Cancer 315181 315181 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Examining the characteristics of lung cancer patients admitted to ICU and their outcomes at 3 months post ICU discharge, using medical record review and requiring no direct participant involvement.
Intervention code [1] 316447 0
Not applicable
Comparator / control treatment
No control required (observational)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322408 0
Survival to ICU discharge
Timepoint [1] 322408 0
Time of ICU discharge (open-ended)
Primary outcome [2] 322409 0
Survival at 3 months post ICU discharge
Timepoint [2] 322409 0
3 months post discharge
Primary outcome [3] 322410 0
Survival to hospital discharge
Timepoint [3] 322410 0
Time of hospital discharge (open-ended)
Secondary outcome [1] 378383 0
Anti-cancer treatment recorded in the patient medical records within 3 months of ICU discharge
Timepoint [1] 378383 0
3 months post ICU discharge

Eligibility
Key inclusion criteria
1. Admitted to Sunshine Coast University Hospital ICU between 1/1/2018 and 1/1/2020
2. New or known diagnosis of lung cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 18 years
Patients with secondary malignancies
Patients admitted to ICU for <24hrs
Routine post-operative admissions

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
As the aim of this study is to define the population, the time period to be included in the study is intended to provide as many data points as practical in our health service. It is hoped to collected ~60 data points (based on historical ICU admission estimates).
Data on patient demographics, malignancy characteristics, survival outcomes and anti-cancer treatment will be collected. Standard descriptive statistical techniques will be used and inferential analysis conducted using regression and multi-variate analysis techniques.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2020
Actual
Date of last participant enrolment
Anticipated
29/05/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15572 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 28946 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 304609 0
Hospital
Name [1] 304609 0
Sunshine Coast University Hospital
Country [1] 304609 0
Australia
Funding source category [2] 305428 0
Self funded/Unfunded
Name [2] 305428 0
Dr Zachariah Dawes
Country [2] 305428 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast University Hospital
Address
Sunshine Coast University Hospital
6 Doherty Street
Birtinya, QLD, 4575
Country
Australia
Secondary sponsor category [1] 305818 0
None
Name [1] 305818 0
Address [1] 305818 0
Country [1] 305818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305030 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 305030 0
Ethics committee country [1] 305030 0
Australia
Date submitted for ethics approval [1] 305030 0
14/02/2020
Approval date [1] 305030 0
09/03/2020
Ethics approval number [1] 305030 0
60780

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

Contacts
Principal investigator
Name 99030 0
Dr Zachariah Dawes
Address 99030 0
Sunshine Coast Institute for Critical Care Research 6 Doherty street Birtinya QLD 4575
Country 99030 0
Australia
Phone 99030 0
+61 0458 594 810
Fax 99030 0
Email 99030 0
[email protected]
Contact person for public queries
Name 99031 0
Zachariah Dawes
Address 99031 0
Sunshine Coast Institute for Critical Care Research 6 Doherty street Birtinya QLD 4575
Country 99031 0
Australia
Phone 99031 0
+61 0458 594 810
Fax 99031 0
Email 99031 0
[email protected]
Contact person for scientific queries
Name 99032 0
Zachariah Dawes
Address 99032 0
Sunshine Coast Institute for Critical Care Research 6 Doherty street Birtinya QLD 4575
Country 99032 0
Australia
Phone 99032 0
+61 0458 594 810
Fax 99032 0
Email 99032 0
[email protected]

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:
• Case-by-case basis at the discretion of the Principle Investigator

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified raw data - participant demographics, malignancy characteristics and outcomes

What types of analyses could be done with individual participant data?
• To achieve the aims in the approved proposal and for meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
31/06/2020

To:
01/01/2025

Where can requests to access individual participant data be made, or data be obtained directly?
• Via contact with the Principle Investigator (Email: [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.