Genetic Epidemiology of Lung Cancer and Smoking (EAGLE)
35 Years
79 Years
Both
Lung Cancer
Trial Information
Genetic Epidemiology of Lung Cancer and Smoking (EAGLE)
This is an interdisciplinary multicenter case-control study of lung cancer situated in Milan
Italy, designed to explore the genetic determinants both of lung cancer and of smoking. We
enrolled newly diagnosed lung cancer cases within a defined area around Milan Italy, and
population-based controls from the same area. The study includes biospecimen collection as
well as epidemiological and clinical data.
This is an integrated proposal designed to address two major issues: the genetic
determinants of lung cancer and the genetic determinants of smoking. Other important issues
arc addressed in the study with a marginal additional cost to the main design. The study
achieves excellent power for studying the main effects of genetic factors that are
relatively common and good power for formal tests of interactive eftects.
Using a case-control design, with questionnaire, medical record abstraction, and blood
collection. we can investigate:
- main effects of genes on lung cancer risk
- gene-environment and gene-gene effects in lung cancer etiology
- gene effects on smoking persistence
- genes effects on ever-never smoking
In addition, we have collected viable lymphocytes from all study subjects and tumor,
metaplastic and normal tissue samples from at least 400 surgical cases. With these data and
tissues, we can study:
- genetic instabilities in lung cancer tissue in relation to specific exposures,
genotype, persistence of smoking, and clinical presentation of lung cancer;
- histologic characteristics of lung cancer in relation to genotype, gene expression,
methylation. somatic mutations, and smoking;
- functional assays in viable lymphocytes in relation to genotype, gene expression
Moreover. we are collecting clinical reports of treatments, quality of life, recurrence,
toxicities, and survival from all cases that consented. With this material we will be able
to link the genetic profiles of the cases with data on therapy efficacy, toxicity and
survival, to contribute to the improvement of treatment for lung cancer.
Inclusion Criteria
- INCLUSION CRITERIA - CASE GROUP:
The case group will consist of 2,000 newly incident lung cancer cases, male and female, 35
to 79 years old, with verified lung cancer, collected before or after surgery and prior to
chemotherapy or radiation therapy.
All histologic types and all stages of lung cancer will be eligible.
Cases will be consecutively collected in the departments of thoracic surgery, general
surgery, general medicine, and oncology.
The pool of cases will be residents of Lombardy derived from 5 cities (Milan, Brescia,
Varese, Monza, and Pavia) and the surrounding residential villages served by 14 hospitals,
that encompass all five medical schools in the region.
Enrolled cases will have no history of other cancers, except for basal cell carcinoma of
the skin or in situ cervical carcinoma.
Subjects in intensive care units, or with cardiac, hepatic, renal, or CNS failure, or with
uncompensated schizophrenia, psychosis, or inability to speak, will not be enrolled.
All subjects will sign an informed consent.
INCLUSION CRITERIA - CONTROL GROUP:
The control group will consist of 2,000 gender-, age-, and county-matched controls with no
history of cancer.
We will choose a population-based or hospital-based control group depending on the result
of a pilot study.
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Maria T Landi, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
999901211
NCT ID:
NCT00340340
Start Date:
June 2001
Completion Date:
Related Keywords:
- Lung Cancer
- Candidate Gene
- Population-Based Case Control Study
- Gene-Environment
- Lung Cancer
- Epidemiology
- Smoking
- Smokers
- Genetics
- Lung Neoplasms
- Smoking
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