Liverpool Lung Project
45 Years
79 Years
Both
Health Status Unknown, Lung Cancer
Trial Information
Liverpool Lung Project
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.
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
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
Principal Investigator
John K. Field, MA, BDS, PhD, FRCPath
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Liverpool Cancer Research Centre
Authority:
Unspecified
Study ID:
ULCRC-LLP
NCT ID:
NCT00503958
Start Date:
August 1998
Completion Date:
Related Keywords:
- Health Status Unknown
- Lung Cancer
- non-small cell lung cancer
- small cell lung cancer
- health status unknown
- Lung Neoplasms
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