Lung Cancer Clinical Trial; Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer

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Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2007
Sponsored by: University of Liverpool Cancer Research Centre

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00503958

Purpose
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 randomized phase I trial is studying risk factors and genetic markers in healthy participants and in patients with lung cancer.



Condition Intervention Phase
Health Status Unknown
Lung Cancer
Genetic: DNA methylation analysis
Genetic: DNA stability analysis
Genetic: gene expression analysis
Procedure: biopsy
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors
Procedure: study of socioeconomic and demographic variables
Phase I




MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources
Study Type: Observational
Official Title: Liverpool Lung Project


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
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)


Estimated Enrollment: 8300
Study Start Date: August 1998
Detailed Description:
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.

Eligibility


Ages Eligible for Study: 45 Years to 79 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Criteria
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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503958


Locations
United Kingdom
Cardiothoracic Centre - Liverpool Recruiting
Liverpool, United Kingdom, L14 3PE
Contact: Contact Person 44-151-228-1616
United Kingdom, England
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 peter.clark@ccotrust.nhs.uk
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
Whiston Hospital Recruiting
Prescot Merseyside, England, United Kingdom, L35 5DR
Contact: Ernest Marshall, MD 44-151-426-1600

Sponsors and Collaborators
University of Liverpool Cancer Research Centre
Investigators
Principal Investigator: John K. Field, MA, BDS, PhD, FRCPath University of Liverpool Cancer Research Centre

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000554297, ULCRC-LLP, EU-20735
Study First Received: July 17, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00503958 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
small cell lung cancer
health status unknown
non-small cell lung cancer
small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Small Cell
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Healthy
Carcinoma, Non-Small-Cell Lung



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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