Liverpool Lung Project
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8,300
- 试验地点
- 5
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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)
次要结局
未报告次要终点