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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02871856




Registration number
NCT02871856
Ethics application status
Date submitted
8/08/2016
Date registered
18/08/2016

Titles & IDs
Public title
International Lung Screen Trial (ILST)
Scientific title
International Lung Screen Trial
Secondary ID [1] 0 0
HREC/16/QPCH/181
Universal Trial Number (UTN)
Trial acronym
ILST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Lung Neoplasms 0 0
Respiratory Tract Neoplasms 0 0
Thoracic Neoplasms 0 0
Neoplasms by Site 0 0
Neoplasms 0 0
Lung Diseases 0 0
Respiratory Tract Diseases 0 0
Smokers at Risk of Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Any cancer
Cancer 0 0 0 0
Other cancer types
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Low dose CT

Other: Single - Single arm only, CT screening of lung


Diagnosis / Prognosis: Low dose CT
low-dose screening CT of chest for lung cancer detection
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of Lung cancers
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Number of nodules
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Change in quality of life
Timepoint [3] 0 0
5 Years
Secondary outcome [1] 0 0
Cancer detection rate
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Types and number of investigations
Timepoint [2] 0 0
5 Years

Eligibility
Key inclusion criteria
*
* Women or men age from 55 to 80.
* Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
* An estimated 6-year lung cancer risk of =1.51% based on the PLCOm2012 risk prediction model or = 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
* ECOG performance status 0 or 1.
* Capable of providing, informed consent for screening procedures (low dose spiral CT)
*
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
* Clinical symptoms suspicious for lung cancer e.g. hemoptysis, chest pain, weight loss
* Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject's safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities
* Have been previously diagnosed with lung cancer
* Have had other non-curatively treated cancer outside the lung.
* Pregnancy
* Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks
* Unwilling to have a spiral chest CT
* Chest CT within 2 years
* Does not fit into CT scanner table due to gross obesity
* Cannot lie on CT scanning table on the back with arms over the head
* Received chemotherapy or cytotoxic drugs within the last 6 months
* Unwilling to sign a consent

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment postcode(s) [5] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kwun M Fong
Address 0 0
UQTRC at TPCH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02871856