Lung Cancer Clinical Trial
Official title:
Liverpool Lung Project
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.
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.
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