International Lung Screen Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- The University of Queensland
- Enrollment
- 2000
- Locations
- 6
- Primary Endpoint
- Change in quality of life
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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
\[insert site name\]
Investigators
Kwun Fong
Professor
The University of Queensland
Eligibility Criteria
Inclusion Criteria
- •Women or men age from 55 to
- •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
- •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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in quality of life
Time Frame: 5 Years
Number of nodules
Time Frame: 5 years
The number of Lung cancers
Time Frame: 5 years
Secondary Outcomes
- Cancer detection rate(5 years)
- Types and number of investigations(5 Years)