International Lung Screen Trial (ILST)

Not Applicable

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Neoplasms; Smokers at Risk of Lung Cancer
• Interventions: Diagnostic Test: Low dose CT

• Registration Number: NCT02871856
• Lead Sponsor: The University of Queensland

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.

Detailed Description

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Study Timeline

• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2017-04-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	Low dose CT	Single arm only, CT screening of lung

Primary Outcome Measures

Name	Time	Method
Change in quality of life	5 Years
Number of nodules	5 years
The number of Lung cancers	5 years

Secondary Outcome Measures

Name	Time	Method
Cancer detection rate	5 years
Types and number of investigations	5 Years

Trial Locations

Locations (6)

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia

Fiona Stanley Hospital; 🇦🇺 Perth, Western Australia, Australia

The Prince Charles Hospital; 🇦🇺 Brisbane, Queensland, Australia

St Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia

BC Cancer Research Centre; 🇨🇦 Vancouver, British Columbia, Canada

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia