Genetic Epidemiology of Lung Cancer and Smoking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00340340
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

We will conduct an interdisciplinary case-control/sib-pair study of lung cancer designed to explore the genetic determinants both of lung cancer and of smoking. The study includes biospecimen collection as well as exposure information with power to address main genetic effects and gene-environment interactions.

This is an integrated proposal designed to address two major issues: the genetic determinants of lung cancer in smokers and the genetic determinants of smoking. Other important issues will be 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 effects.

Using a case-control design, with questionnaire, medical record abstraction, and blood collection, we will investigate: main effects of genes on lung cancer risk; gene-environment and gene-gene effects in lung cancer etiology; gene effects on smoking persistence; gene effects on ever-never smoking; gene-psychological interactions in smoking behaviors.

In addition, we will collect viable lymphocytes from all study subjects and tumor, metaplastic and normal tissue samples from 100 surgical cases. With these data and tissues, we will be able to 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, somatic mutations, and smoking; functional assays in viable lmphocytes in relation to genotype, gene expression.

Finally, we will identify lung cancer-affected siblings of cases, and the unaffected siblings in the same sibships. This sample will permit us to: replicate associations found in the case-control sample with an alternative analytical method based on transmission statistics; address some population stratification issues.


Condition
Lung Cancer

Study Type: Observational
Official Title: Genetic Epidemiology of Lung Cancer and Smoking (EAGLE)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 4500
Study Start Date: June 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00340340

Locations
Italy
Ospedale Fatebenefratelli Sant'Orsola
Brescia, Italy
Spedali Civili
Brescia, Italy
Azienda Ospedaliera San Paolo
Milan, Italy
Euromedia Marketing Service
Milan, Italy
Universita Degli Studi di Milano
Milan, Italy
Ospedale San Giuseppe
Milan, Italy
Ospedale Maggiore di Milano
Milan, Italy
Istituti Clinici de Perfezionamento ICP
Milan, Italy
Hosp Niguarda Ca Granda
Milan, Italy
Fondazione Centro San Raffaele - HSR
Milan, Italy
Ospedale San Carlo Borromeo
Milan, Italy
L'Azienda Ospedaliera Fatebenefratelli e Oftalmico
Milan, Italy
Interfield
Milano, Italy
Azienda Ospedaliera Luigi Sacco
Milano, Italy
Azienda Ospedaliera San Gerardo
Monza-Milano, Italy
Policlinico San Matteo
Pavia, Italy
Instituto Clinica Humanitas - ICH
Rozzano-Milan, Italy
Azienda Ospedale di Circolo di Varese
Varese, Italy
Sponsors and Collaborators
Investigators
Principal Investigator: Maria T Landi, M.D. National Cancer Institute (NCI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00340340     History of Changes
Other Study ID Numbers: 999901211, 01-C-N211
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Candidate Gene
Population-Based Case Control Study
Gene-Environment
Lung Cancer
Epidemiology
Smoking
Smokers
Genetics

Additional relevant MeSH terms:
Lung Neoplasms
Smoking
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Habits

ClinicalTrials.gov processed this record on July 23, 2014