International Lung Screen Trial (ILST)

Sponsor

The University of Queensland (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02871856

Collaborator

(none)

2,000

Enrollment

Locations

Arm

79.9

Anticipated Duration (Months)

333.3

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

People who may be at increased risk of lung cancer due to age and smoking history will be invited to participate in this international study to determine the best way of using computed tomography (CT) of the chest to screen for early lung cancer. Overseas data show that CT screening (screening tests can find diseases early, when they're easier to treat) can reduce deaths from lung cancer and this study will help determine who is most likely benefit from screening.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Smokers at Risk of Lung Cancer	Diagnostic Test: Low dose CT	N/A

Detailed Description

[insert site name]

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

International Lung Screen Trial

Actual Study Start Date :

Apr 5, 2017

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Single Single arm only, CT screening of lung	Diagnostic Test: Low dose CT low-dose screening CT of chest for lung cancer detection

Arm

Intervention/Treatment

Other: Single

Single arm only, CT screening of lung

Diagnostic Test: Low dose CT

low-dose screening CT of chest for lung cancer detection

Outcome Measures

Primary Outcome Measures

The number of Lung cancers [5 years]
Number of nodules [5 years]
Change in quality of life [5 Years]

Secondary Outcome Measures

Cancer detection rate [5 years]
Types and number of investigations [5 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Vincent's Hospital	Sydney	New South Wales	Australia	2010
2	The Prince Charles Hospital	Brisbane	Queensland	Australia	4032
3	Royal Melbourne Hospital	Melbourne	Victoria	Australia	3050
4	Sir Charles Gairdner Hospital	Perth	Western Australia	Australia	6009
5	Fiona Stanley Hospital	Perth	Western Australia	Australia	6150
6	BC Cancer Research Centre	Vancouver	British Columbia	Canada	V5Z1L3