International Lung Screen Trial (ILST)

Non-small Cell Lung Cancer Clinical Trial

— ILST  

Official title:

International Lung Screen Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02871856
• Other study ID #: HREC/16/QPCH/181
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Neoplasms
• Neoplasms
• Neoplasms by Site
• Non-small Cell Lung Cancer
• Respiratory Tract Diseases
• Respiratory Tract Neoplasms
• Smokers at Risk of Lung Cancer
• Thoracic Neoplasms

Intervention

Diagnostic Test:
• Low dose CT
low-dose screening CT of chest for lung cancer detection

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Perth	Western Australia
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	St Vincent's Hospital	Sydney	New South Wales
Canada	BC Cancer Research Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
The University of Queensland

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of Lung cancers		5 years
Primary	Number of nodules		5 years
Primary	Change in quality of life		5 Years
Secondary	Cancer detection rate		5 years
Secondary	Types and number of investigations		5 Years