C34
Conditions
Interventions
Group 1: standard arm: Current lung cancer screening guidelines generally recommend annual screening. Individuals in this arm will receive two more screens after the baseline screening, with an annual
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Age
55 Years to 77 Years
Inclusion criteria
Inclusion criteria: 1) a smoking history of at least 30 pack-years (1 pack equals 20 cigarettes) and being a current smoker or a former smoker who quit less than 15 years prior or 2) a PLCOm2012 model 6-year risk for lung cancer incidence over 1.83%.
Exclusion criteria
Exclusion criteria: 1. Recent abnormal pulmonary findings under work-up of standard care. 2. Having had a computed tomography scan of the thorax <1 year before potential entry into the study. 3. Current or prior history of lung cancer, renal cancer, melanoma or breast cancer. 4. Inability to provide signed informed consent. 5. Insufficient understanding of the languages in which trial information is available. 6. Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up. 7. Unable to be followed-up for at least 5-years. 8. Body weight over 140 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of stage II or lower lung cancer, assessed at the end of the recruitment in 2 years, the cumulative hazard functions of stage I/II cancers between the two randomized groups will be compared using a logrank test. The stage I/II cancers rate for each arm will be estimated as the number of stage I/II cancers detected clinically or through screening out of the total person-years of follow-up in their respective arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of (late stage) interval cancers in each arm. 2. The rates of smoking cessation within individuals in the trial smoking at the baseline screening. 3. The crude costs and cost-effectiveness of each arms. 4. Policies for risk-stratification through biomarkers. 5. The external validation and update/extension of various lung cancer risk-prediction models in 4-IN-THE-LUNG-RUN 6. Guidelines and training programmes for CT screening and pulmonary nodule management. 7. Overview of sex and gender differences in lung cancer risk and screening effectiveness. 8. Overview of SES and gender representativeness within the trial. 9. Comparison and merging of results with other ongoing European studies. | — |
Countries
France, Germany, Italy, Netherlands, Spain
Contacts
Public ContactRudolf Kaaks
German Cancer Research Center (DKFZ)
Outcome results
None listed