International Lung Screen Trial (ILST)

Study Overview
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Brief Summary
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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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[insert site name]

Official Title
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International Lung Screen Trial

Conditions
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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

Intervention / Treatment
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* Diagnostic Test: Low dose CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single<br>Single arm only, CT screening of lung | Diagnostic Test: Low dose CT<br>* low-dose screening CT of chest for lung cancer detection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of Lung cancers |  | 5 years | 
| Number of nodules |  | 5 years | 
| Change in quality of life |  | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer detection rate |  | 5 years | 
| Types and number of investigations |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Computed tomography, Lung cancer