International Lung Screen Trial (ILST)

The University of Queensland

Status: Active, not recruiting

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

Treatments: Diagnostic Test: Low dose CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02871856

HREC/16/QPCH/181

Details and patient eligibility

About

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.

Full description

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Enrollment: 2,000 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Single

Other group

Description:

Single arm only, CT screening of lung

Treatment:

Diagnostic Test: Low dose CT