Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future. PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.

Detailed Description
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OBJECTIVES: To prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer. To develop an archive of specimens relating to at-risk individuals and those with lung cancer. To redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability. To identify and assess novel markers of pre-carcinogenesis in our high-risk populations. To facilitate the development of new intervention strategies (i.e., chemoprevention). OUTLINE: This is a multicenter study. Participants and/or patients undergo tumor tissue, sputum, and blood sample collection periodically. Samples are analyzed via fields of expression and methylation profiling and genetic instability. Samples are also archived. Complete lifetime lifestyle, residential, environmental tobacco smoke, and occupational history are assessed in the first year and then in year five and year ten. Participants who return for follow-up complete a shorter questionnaire aimed at recording change over the interval since their last attendance. PROJECTED ACCRUAL: 800 patients and 7,500 healthy participants will be accrued for this study.

Official Title
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Liverpool Lung Project

Conditions
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Health Status Unknown, Lung Cancer

Intervention / Treatment
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* Genetic: DNA methylation analysis
* Genetic: DNA stability analysis
* Genetic: gene expression analysis
* Other: epidemiologic study
* Other: study of socioeconomic and demographic variables
* Procedure: biopsy
* Procedure: evaluation of cancer risk factors
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Prospective cohort: All residents (n=326,000), aged 45-79, within the designated Liverpool postcode study area will be eligible for entry into the study 7,500 people will be randomly selected from this population via general practitioner's (GP's) lists held by each Primary Care Trust All the GP's who have practices within the study area will be asked to collaborate with the project Case-control: Patients: Newly diagnosed cases of primary lung cancer All cases of epithelial tumors of the trachea, bronchus, and lung will be included Two controls per case who are matched for age (+/- 2 years) and gender and will be randomly selected from the Liverpool Lung Project prospective cohort PATIENT CHARACTERISTICS: Inclusion Criteria: Prospective cohort: Age 45-79 Living within the Liverpool electoral wards Case-control: Upper age limit of 80 years old Resident within Liverpool Lung Project area Exclusion Criteria: Both cohorts: Unable to provide competent informed consent Ineligible to approach based on consultant/clinical team advice Infectious respiratory disease (i.e., chest infection and are on antibiotics) within the past 3 months Untreated pulmonary tuberculosis within the past 3 months PRIOR CONCURRENT THERAPY: Participant and/or patient must not have had any of the following treatments within the last 3 months and is not planning to undergo any of them: Cardiac surgery Thoracic surgery Carotid artery surgery Abdominal surgery Chemotherapy Deep x-ray therapy

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA methylation analysis|nan|
|Genetic: DNA stability analysis|nan|
|Genetic: gene expression analysis|nan|
|Other: epidemiologic study|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: biopsy|nan|
|Procedure: evaluation of cancer risk factors|nan|
|Procedure: study of high risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer |  |  | 
| Develop an archive of specimens relating to at-risk individuals and those with lung cancer |  |  | 
| Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability |  |  | 
| Identify and assess novel markers of pre-carcinogenesis in high-risk populations |  |  | 
| Facilitate the development of new intervention strategies (i.e., chemoprevention) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer, health status unknown