The study was conducted in the Lombardy region of Italy, which includes approximately 9,600,000 people and is served by a network of modern hospitals, medical schools, and a regional health service. The catchment area includes 5 cities (Milan, Monza, Brescia, Pavia, and Varese) and surrounding towns and villages, for a total of 216 municipalities, encompassing over 3,000,000 people. The theoretical ideal is random collection of cases from the population, e.g., through a cancer registry. However, random selection from hundreds of large and small hospitals would have made collection of biospecimens (particularly fresh frozen tissue samples) and detailed epidemiological and clinical data unfeasible. Thus, we designed EAGLE to be as close as possible to a really comprehensive population-based study through enrollment of cases in a defined set of hospitals, which examine approximately 80% of all lung cancer cases from the catchment area. These hospitals were selected based on a review of the hospital admission/discharge records from the years 1997–2000.
EAGLE includes 2101 verified, incident, primary lung cancer cases of any histologic type, with the exception of carcinoids, and 2120 healthy population-based controls. Participants are both male and female, born in Italy, of Italian nationality, and with official residence in the 216 selected municipalities, at ages between 35 and 79 years old at diagnosis (cases) or enrollment for interview (controls) that signed an informed consent form to participate in the study. The study was approved by the Institutional Review Board (IRB) of each participating hospital and university in Italy and by the National Cancer Institute, Bethesda, MD.
EAGLE's study size is powered to detect small increases in risk for factors with moderate frequency; for example the power is at least 80% to detect an association between a given genotype and lung cancer risk with an OR of 1.4 for at-risk genotype frequency between 10% and 90%. Under a multiplicative gene-environment interaction model, the study is large enough to reject at a 0.05-level with 80 percent power an interaction of 0.5 between the highest smoking category relative to the non-smoking category when the at-risk genotype frequency is > 13%, and of 0.2, if the at-risk genotype frequency is 5% or higher and the distributions of smoking and the gene are independent [7 (link)].
EAGLE includes 2101 verified, incident, primary lung cancer cases of any histologic type, with the exception of carcinoids, and 2120 healthy population-based controls. Participants are both male and female, born in Italy, of Italian nationality, and with official residence in the 216 selected municipalities, at ages between 35 and 79 years old at diagnosis (cases) or enrollment for interview (controls) that signed an informed consent form to participate in the study. The study was approved by the Institutional Review Board (IRB) of each participating hospital and university in Italy and by the National Cancer Institute, Bethesda, MD.
EAGLE's study size is powered to detect small increases in risk for factors with moderate frequency; for example the power is at least 80% to detect an association between a given genotype and lung cancer risk with an OR of 1.4 for at-risk genotype frequency between 10% and 90%. Under a multiplicative gene-environment interaction model, the study is large enough to reject at a 0.05-level with 80 percent power an interaction of 0.5 between the highest smoking category relative to the non-smoking category when the at-risk genotype frequency is > 13%, and of 0.2, if the at-risk genotype frequency is 5% or higher and the distributions of smoking and the gene are independent [7 (link)].
Free full text: Click here
