Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
NCT ID: NCT00503958
Last Updated: 2013-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
8300 participants
OBSERVATIONAL
1998-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Detection of Genetic Markers of Lung Cancer
NCT00280202
Prospective Analysis of Genotypes in Adults Undergoing Therapy for Lung Cancer
NCT00923884
Studying Patterns, Causes, and Control of Disease in Patients With Lung Cancer in the North Trent (England) Region
NCT00693836
Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
NCT00899028
Molecular Markers in Predicting Lung Cancer Development Using Tissue Samples From Healthy Participants
NCT00899457
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DNA methylation analysis
DNA stability analysis
gene expression analysis
epidemiologic study
study of socioeconomic and demographic variables
biopsy
evaluation of cancer risk factors
study of high risk factors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
* 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
* 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
45 Years
79 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liverpool Cancer Research Centre
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John K. Field, MA, BDS, PhD, FRCPath
Role: PRINCIPAL_INVESTIGATOR
University of Liverpool Cancer Research Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Liverpool Cancer Research Centre
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
Whiston Hospital
Prescot Merseyside, England, United Kingdom
Cardiothoracic Centre - Liverpool
Liverpool, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
John K. Field, MA, BDS, PhD, FRCPath
Role: primary
Contact Person
Role: primary
Ernest Marshall, MD
Role: primary
Contact Person
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDR0000554297
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20735
Identifier Type: -
Identifier Source: secondary_id
ULCRC-LLP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.