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Clinical Trials/NCT02871856
NCT02871856
Active, not recruiting
Not Applicable

International Lung Screen Trial

The University of Queensland6 sites in 2 countries2,000 target enrollmentApril 5, 2017

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

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Registry
clinicaltrials.gov
Start Date
April 5, 2017
End Date
December 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (6)

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