Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
|ClinicalTrials.gov Identifier: NCT00503958|
Recruitment Status : Unknown
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 19, 2007
Last Update Posted : May 15, 2013
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.
|Condition or disease||Intervention/treatment|
|Health Status Unknown Lung Cancer||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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||8300 participants|
|Official Title:||Liverpool Lung Project|
|Study Start Date :||August 1998|
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503958
|University of Liverpool Cancer Research Centre||Recruiting|
|Liverpool, England, United Kingdom, L3 9TA|
|Contact: John K. Field, MA, BDS, PhD, FRCPath 44-151-794-8900|
|Aintree University Hospital||Recruiting|
|Liverpool, England, United Kingdom, L9 7AL|
|Contact: Contact Person 44-151-525-5980|
|Clatterbridge Centre for Oncology||Recruiting|
|Merseyside, England, United Kingdom, CH63 4JY|
|Contact: Peter Clark, MD 44-151-482-7828 firstname.lastname@example.org|
|Prescot Merseyside, England, United Kingdom, L35 5DR|
|Contact: Ernest Marshall, MD 44-151-426-1600|
|Cardiothoracic Centre - Liverpool||Recruiting|
|Liverpool, United Kingdom, L14 3PE|
|Contact: Contact Person 44-151-228-1616|
|Principal Investigator:||John K. Field, MA, BDS, PhD, FRCPath||University of Liverpool Cancer Research Centre|