Frequently Asked Questions
What does EAGLE Stand for?
Environment And Genetics in Lung Cancer Etiology
What is the study design?
EAGLE is a large, multicenter, population–based molecular epidemiology case-control study of lung cancer with a major biospecimen component conducted in the Lombardy Region of Italy from 2002-2005.
What is the purpose of the study? Don’t we already know that smoking causes lung cancer?
The role of smoking has been well-documented in lung cancer for over 50 years. Less well-understood is why only 15-20% of smokers are afflicted with lung cancer and a small proportion of lung cancer occurs in the absence of smoking. A key goal of the study is to understand the role of inherited variation in smokers with lung cancer.
Who are the collaborators in the study?
Maria Teresa Landi and Neil Caporaso are the co-Principal Investigators (PI) of the study.
Pier Alberto Bertazzi is the head of the coordinating center in Italy, Angela Pesatori and Dario Consonni play key roles in management and coordination, and database operations, respectively. Other key Italian and US collaborators are listed under COLLABORATORS, elsewhere on this website.
Is it possible to collaborate with the study?
Epidemiologists or others interested in collaboration should contact either Dr. Landi or Dr. Caporaso for more information. Collaborations with scientifically and ethically appropriate investigators are welcomed.
How many subjects participated in EAGLE?
There are over 2000 lung cancer cases and 2000 population-based controls in the study.
When did the study take place?
The study was conceived, organized and planned by Dr. Landi and Dr. Caporaso in the late 1990’s. A series of ethical, administrative, and scientific approvals were obtained. Initial approval of the concept entitled, ‘Genetic Epidemiology of Lung Cancer and Smoking’ was obtained on September 2, 1999 and a follow-up revision was approved on April 9, 2003 from the Division of Cancer Epidemiology and Genetics, Senior Advisory Group. The contract, ‘Genetic Epidemiology of Lung Cancer and Smoking’ was awarded September 30, 2000 to EPOCA. A pilot study was conducted in 2001 and formal field operations of the study began in April 2002 and concluded in 2005. Currently, data clean up, database formation, preparatory laboratory work (i.e. DNA extraction, pilot studies of various markers) have been completed, and analyses of epidemilogic variables and genetic markers are ongoing.
What information was collected on EAGLE participants?
Participants in the study complete 2 large questionnaires. One is a computer-assisted programmed instrument (CAPI) that includes information on lung cancer risk factors that include questions on demographics, detailed smoking history (quitting history, other tobacco use), family history of lung cancer and other cancers, occupational exposures, environmental tobacco smoke history, medical history, and residential history.
The second, SELF-ADMINISTERED questionnaire includes questions on personality, anxiety and depression, attention and ability to focus, diet, meat preparation method and doneness, alcohol consumption, attitudes about smoking, and stages of quitting.
Two additional questionnaires including a subgroup of the questions in the CAPI and Self –administered questionnaires were administered to next of kin and siblings of the affected individuals if needed.
A variety of other clinical forms and documentation, i.e, detailing staging, imaging, clinical laboratory results, pathology reports and others are also available.
What biospecimens are collected on EAGLE participants?
Subjects contributed blood (which is divided into various components for storage including serum, plasma, buffy coat, red blood cells, DNA, RNA, whole blood, and blood cards) or, in rare occasions, buccal cell samples. Tissue blocks, tissue slides, and fresh tissue (frozen in liquid nitrogen) were obtained from operative candidates. The proportion of subjects from whom genetic material is available is close to 100%.
What types of quality control were built into the study?
To insure integration of process across institutions, at the beginning of the project we created Standard Operating Procedures (SOPs) and planned and conducted Quality Assurance/Quality Control visits on a periodic basis. Weekly conference calls were held throughout the course of the study to monitor adherence with study procedures and to assess milestones. A few times a year, in person site visits were conducted where laboratory, data storage facilities, and hospitals were visited and meetings where conducted with key personnel. When necessary, special meetings were arranged to deal with problems, occasionally by video conference. Site visits often included scientific presentations. Monthly and annual reports were reviewed. Study progress was also reported to a group of investigators from the Division of Cancer Epidemiology and Genetics of NCI that assessed study activity and recommended technical, scientific or management changes when appropriate. Detailed study manuals covering procedures for Research Physicians, Laboratory personnel, Data Processing Center staff were in place.
What are some of the ethical protections in the study?
The study has undergone formal ethical review and received approval from Institutional Review Board (IRB) at the National Cancer Institute. The participating hospitals and the Coordinating Center in Italy also have formally constituted ethical bodies which have reviewed the study. The IRB’s in Italy and in the United States revisit the study on a yearly basis. All study subjects received a detailed informed consent that they signed in order to participate. Subjects could refuse to participate in any part of the study, for example, an individual could elect to complete a questionnaire, but refuse to contribute any blood. No tissue was obtained, if it was required for clinical tests. All study procedures were conducted using standard operating procedures (SOPs) to maximize patient and staff safety, and to insure the scientific integrity of the results. Data were stored free of patient identifiers.
Why is the study unique?
EAGLE is one of the largest case-control studies of lung cancer in the world, with hish response rate in cases and controls. It is the only case-control study of this size and extensive biospecimen collection to be population based. The study is integrative, that is it anticipates testing and combining multiple epidemilogical, clinical, behavioral, and laboratory-based questions in lung cancer.
What are the future plans for the study?
A variety of descriptive and technology-based analyses involving lung cancer and smoking are planned. Collection of information on lung cancer treatment and outcome, quality of life and survival is planned for late 2006-2007.